Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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21st Century Cures Law Favors Drug Approval Speed Over Science, Say Kesselheim & Avorn

21st Century Cures Law Favors Drug Approval Speed Over Science, Say Kesselheim & Avorn | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The 21st Century Cures Act was signed into law in December 2016. Praised by its advocates as a means of speeding drug development, the act covers several areas, but the provisions related to the US Food and Drug Administration (FDA) will be among the most problematic and potentially important. An earlier version was passed with a wide margin by the House of Representatives in July 2015; it contained sweeping measures to permit manufacturers to submit less rigorous data to the FDA for approval of drugs and devices, and it recommended annual increases to the National Institutes of Health (NIH) budget of approximately 3% per year for 3 years as well as approximately $8.75 billion over 5 years in additional support

 

Among the most concerning sections of the new law are components that address the types of data that manufacturers will be able to use to gain FDA approval of new products or additional indications for existing products. One section directs the Secretary of Health and Human Services to qualify “drug development tools” to facilitate new drug approval. These include biomarkers, surrogate measures, other assessments, and “any other method, material or measure that the Secretary determines aids drug development.” Another provision instructs the Secretary to develop pathways to facilitate submission of “patient experience” information in regulatory decision-making. A third requires the Secretary to establish a program to use “real world evidence”—observational data arising from routine clinical use, rather than prospectively collected data from randomized controlled trials—to support the approval of new uses of existing drugs.

 

In fact, most of these data elements are already used by the FDA, with about half of all new drugs now approved on the basis of biomarkers and other surrogate measures. Overreliance on such measures has recently led to approval of treatments for muscular dystrophy, tuberculosis, and metastatic breast cancer. When biomarkers used as the basis for drug approval are not rigorously validated, they may not actually predict patient benefit, can mislead physicians about whether a drug works, and have the potential to expose patients to poorly effective treatments or unanticipated adverse effects.6 These sections of the bill increase the probability that insufficiently tested biomarkers could be “qualified” under orders from the Secretary. Remarkably, scientific merit is not a mandatory component; instead, the act says, “The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the qualification submission” [emphasis added]. Use of such biomarkers and surrogate measures is further encouraged in another section of the statute that instructs the FDA to “maximize the use” of these assessment tools in approving genetically targeted therapies for rare diseases, which could undermine the role of more demanding trials that assess actual clinical outcomes. These conditions now include large numbers of patients with malignancies that have specific tumor markers or genotypes. Similarly, patient-reported outcomes, which can provide important insights about symptom relief, are commonly measured in pivotal trials, but the placebo effect renders their use outside double-blind randomized trials potentially misleading.

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Up Until Now, GSK Bet on Vaccines Rather than Trendy Immuno-Oncology Cancer Treatments

Up Until Now, GSK Bet on Vaccines Rather than Trendy Immuno-Oncology Cancer Treatments | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Bucking biopharma’s trend in 2014, GlaxoSmithKline CEO Andrew Witty swapped off his oncology assets to Novartis, building his company’s position in vaccines and consumer healthcare instead.

 

Fast-forward to the future. After taking flak from prominent investors, Witty continues to defend the logic—and in recent quarters, he's had the numbers to back up that contention. He continues to make the case that high-priced treatments don't make business sense in the long run.

 

Consider immuno-oncology. Speaking Tuesday at the opening of GSK’s Rockville, Maryland, vaccine research site, Witty said that he doesn’t see pricey immunotherapies for cancer, now biopharma’s hottest field, as a “cost-effective … global healthcare solution.”

 

To back up his point, Witty said the number of patients treated by the last 20 top-selling pharma products has dropped “catastrophically” in recent decades.

 

“A blockbuster drug of the '80s probably treated tens or hundreds of millions. In the '90s it was tens of millions, and now you are into tens of thousands," he said. "Vaccines are going the other way.”

 

Witty said believes the returns to shareholders are “very similar” for vaccines and pharmaceuticals. What’s different is the shape of the return curves.

 

 

With vaccines, a business with high barriers to entry driven by volume on a lower price point, companies can eke out similar profits, the CEO said.

 

By focusing on vaccines and consumer healthcare, Witty bet GSK’s future on lower-margin businesses in a move that so far seems to have paid off. Pricing pressure has taken a toll on the pharmaceutical industry, and GSK’s vaccines have outperformed other units in the second and third quarters this year.

Pharma Guy's insight:

Witty said that he doesn’t see pricey immunotherapies for cancer, now biopharma’s hottest field, as a “cost-effective … global healthcare solution.”

 

It's interesting that Witty used "global" to qualify his remark. In the U.S. a pharma company can usually charge what the market will bear. Therefore, I don't see GSK giving up that lucrative market especially after the 21st Century Act has been signed into law.

 

Related article: “When Does It Makes Economic Sense for #Pharma Industry to Develop Vaccines vs Drugs?”: http://sco.lt/7adpSb

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Congress Will Scrap Reporting Exemption for #Pharma Payments for CME/Textbooks from 21st Century Cures Act

Congress Will Scrap Reporting Exemption for #Pharma Payments for CME/Textbooks from 21st Century Cures Act | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Amid intense criticism, lawmakers have removed a controversial provision in the 21st Century Cures Act that would have exempted companies from reporting payments made to doctors for receiving continuing medical education sessions, medical journals, or textbooks (read “21st Century Cures Bill Would Weaken the Sunshine Act Provision in the Affordable Care Act”; http://sco.lt/6655If).

The provision “is not going to be in the bill when it gets to the House floor” on Wednesday for a vote, a spokeswoman for Rep. Diana DeGette, a Democrat from Colorado, wrote us. The change came one day after Sen. Chuck Grassley (R-Iowa) threatened to put a hold on the entire bill unless the language was removed. We asked the House Energy and Commerce Committee for comment and will pass along any reply.

The exemption — which was widely supported by drug and device makers, as well as physicians — was an attempt to roll back requirements for reporting such payments to a federal database that tracks financial relationships between companies and physicians.

Pharma Guy's insight:

Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

 

Nov. 30, 2016

 

Note: Today, the U.S. House of Representatives passed the 21st Century Cures Act. View Public Citizen’s updated summary (PDF) of the dangerous provisions in the legislation.

 

The U.S. House of Representatives, after weeks of secret deliberations, today passed the dangerous 21st Century Cures Act. The bill has been sold erroneously as a commonsense, bipartisan compromise that enables scientific innovation and medical breakthroughs for America. But in reality, the legislation includes a grab bag of goodies for Big Pharma and medical device companies that would undermine requirements for ensuring safe and effective drugs and medical devices.

 

Moreover, many House members were persuaded to support the bill, despite the many harmful provisions, in exchange for promises of increased funding for the National Institutes of Health (NIH). But there is no guarantee that this funding will be appropriated by Congress in future years. Permanently weakening the U.S. Food and Drug Administration in exchange for tenuous promises of increased NIH funding is a bad deal for patients.

 

We urge the Senate to reject this legislation.

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AMA & Many Other Physician Groups Lobby to Keep CME Payments Out of the Sunshine

AMA & Many Other Physician Groups Lobby to Keep CME Payments Out of the Sunshine | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Nearly 100 national and state medical societies from around the United States are backing a Senate bill (see “21st Century Cures: Hide CME Payments & Allow Off-Label Promotion”; http://sco.lt/62vgQr) that would exempt drug and device makers from reporting payments made to doctors for receiving continuing medical education, or CME, sessions, medical journals, or textbooks. Among them are the American Medical Association and the American College of Cardiology.

 

The move is the latest push in a long-running effort to roll back requirements for reporting such payments to a federal database, which tracks financial relationships between companies and physicians. Known as OpenPayments, the database was launched in 2014 in response to concerns that financial ties between drug firms and device makers and doctors may unduly influence medical practice and research. It was included in the Sunshine Act provision in the Affordable Care Act. A recent analysis found that payments can affect prescription rates.

 

But more than once over the past few years, the Centers for Medicare and Medicaid Services, which maintains the database, appeared to change its mind on reporting requirements for CME payments, in particular. These payments are made by manufacturers or group purchasing organizations to CME providers, which are either commercial firms or nonprofits that organize courses for physicians.

 

CME has been a particularly controversial issue, with accusations that drug and device companies not only fund the courses but they also tightly control the educational curriculum. Last year, industry support for CME totaled $693 million, a 2 percent rise, from the previous year, according to the latest report from the Accreditation Council for Continuing Medical Education, which regulates CME activities.

 

In late 2014, CMS ultimately decided that reporting CME payments would be required. As far as the agency is concerned, medical information — whether in the form of courses, journals, or textbooks — has value that physicians would otherwise have to pay for themselves. However, the CMS decision prompted a lobbying push by industry and medical societies to eliminate the reporting requirement.

 

The support from the medical societies for the bill, which is called the Protect Continuing Physician Education and Patient Care Act, is hardly surprising. In a letter to US Senator John Barrasso, a Wyoming Republican and a physician who introduced the bill, the medical groups argue, however, that Congress initially intended to create such exemptions and CMS may hurt medical practice.

 

“Passage of this bill is urgently needed to remedy onerous and burdensome reporting obligations imposed by CMS that have already chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals, and to avert a similar negative impact on access to independent” CME, they wrote to Barrasso in a June 30 letter.

 

“When a company gives a grant to an accredited CME provider, it’s pretty hands off. They’re not supposed to suggest speakers or influence the curriculum, for instance,” said Thomas Sullivan, president of Rockpointe. “So if a company that supports commercial CE has no control (over the use of its grant dollars), I don’t see why that should be reported. Doctors don’t have the direct relationship with the company.”

 

“It’s a stretch to view free textbook and free medical education as being anything other than a benefit to physicians,” said Daniel Carlat, who runs a company that publishes CME newsletters for mental health practitioners. “These are not direct benefits to patients. The only way these would benefit patients is if a drug company gave free books or courses to patients themselves.”

Pharma Guy's insight:

For a closer look at CME funding data, read "For First Time in Seven Years, Pharma Support of CME Increases"; http://bit.ly/1Ctqf8D 

 

As you can see from the charts, most of the increase in CME funding comes from for-profit CME providers - those so-called "hands-off" 3rd parties. With regards to pharma grants to such groups, it's widely understood that pharma's hands remain "off" perhaps the first time, but if the pharma sponsor is not satisfied with the MECC's CME program, then there may not be a second round of funding via that "independent" CME provider.

 

A Pharma Marketing News survey asked respondents if CME activities that accept commercial support from pharmaceutical companies have more bias that activities that don't and what should be done to limit any potential bias. About one third of respondents said that pharma/device companies should cease funding CME courses provided directly by for-profit, third-party companies (eg, medical education and communication companies), but continue paying for courses offered by medical schools, teaching hospitals and medical societies. Another third disagreed and the rest weren't sure. For more, see http://www.surveys.pharma-mkting.com/PharmaCME.htm

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FDA Officials - Including Commish Nominee Califf - Colluded with Device Industry to Draft "Cures" Legislation

FDA and the largest medical device lobbying group worked together to develop proposed legislative language for most of the medical device provisions included in the House-passed 21st Century Cures bill, one of the largest FDA reform bills to pass the House in recent years, and are developing a synchronized regulatory strategy for the Senate version, according to internal emails and documents obtained by Inside Health Policy through the Freedom of Information Act.


President Barack Obama’s nominee for FDA commissioner, who has come under fire for his past relationships with industry, was aware of the partnership between the agency and the device lobbying group on legislative proposals, according to the emails and documents, and attended meetings with the group along with FDA's acting commissioner and the device center director.


The agency defended the meetings with the device lobbying group as standard procedure and said that Congress requested technical assistance from FDA on the Cures legislation. And, while congressional sources claimed the practice of soliciting outside opinion on legislation was critical to the legislative process, sources off Capitol Hill said they were alarmed at the level of coordination between the agency and the device lobbying group and the amount of influence both parties had over the Cures legislation.


On Aug. 7, FDA officials, including Acting Commissioner Stephen Ostroff, Deputy Commissioner and Commissioner-nominee Robert Califf and Center for Devices and Radiological Health chief Jeff Shuren met with representatives from the Advanced Medical Technology Association (AdvaMed), including Steve Ubl, who then headed the association and is now president of the pharmaceutical drug lobby group, and Janet Trunzo, AdvaMed senior executive vice president of technology and regulatory affairs, as well as individuals from Johnson & Johnson, CVRx Inc. and St. Jude Medical Center.


A background document shared in advance of the meeting with a number of FDA officials, including Califf and Shuren, as well as Larry Morris, executive assistant to Ostroff, Sally Howard, senior advisor and acting chief of staff to Ostroff and Franklin Joseph, associate chief counsel for the agency, notes that FDA and AdvaMed met regularly during the legislative process and that the agency and the device lobbying arm had jointly written legislative text for Energy & Commerce Chairman Fred Upton’s (MI) signature piece of legislation.

Pharma Guy's insight:

Public Citizen said: "It should be unimaginable that the most senior Food and Drug Administration (FDA) officials would collude with the lead medical device trade association to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened. The result is contained within the House-passed 21st Century Cures Act – more accurately known as the False Cures Act – which would eviscerate the already far-too-weak safety rules for medical devices."; http://bit.ly/1lUzR4I

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NYT Editorial: F.D.A. Won't Be Fixed by 21st Century Cures Bill

NYT Editorial: F.D.A. Won't Be Fixed by 21st Century Cures Bill | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A bill passed by the House and ostensibly designed to streamline the Food and Drug Administration is loaded with bad provisions and may not even be necessary. The Senate should either eliminate or rewrite the flawed provisions before passing its version of the legislation.


The bill would weaken the F.D.A.’s already flimsy regulation of medical devices, posing a threat to future patients who have devices implanted that cannot easily be removed if found defective. It would allow a drug to be tested on humans based on only limited evidence that it is safe and effective.


It would expedite the use of new antibiotics by providing financial incentives to hospitals to use them — benefiting manufacturers but also driving up costs and encouraging overuse, potentially breeding resistant superbugs. It would extend exclusive rights for manufacturers to market high-priced, brand-name drugs if they gain a new approval to treat a rare condition. And it would open a wide loophole in rules requiring companies to report payments they make to doctors to get them to prescribe their drugs.


While the bill has some valuable provisions — like making experimental drugs available more quickly to patients who have illnesses that cannot be cured, and promoting the development of treatments based on an individual’s genetic data — those elements don’t justify the bill’s passage in its current form.


The F.D.A. was once routinely vilified for sluggishness and timidity, but with the help of industry funding it has made enormous progress in speeding up its reviews and approvals. The agency testified in April that its drug review times are consistently faster than those of all other advanced regulatory agencies around the world, with the result that American patients receive new drugs sooner than people elsewhere. In 2014, the F.D.A. approved the largest number of new drugs in almost 20 years and also reduced the review times for devices.


A big reason the bill won bipartisan support in the House is that it would increase funding for the National Institutes of Health by $8.75 billion over the next five years, ending a decade of mostly stagnant funding. And any improved Senate version should certainly include new money.


Special interest money also played a role, with many of the top supporters of the legislation having received hundreds of thousands of dollars in contributions from the pharmaceutical industry and the medical device industry last year, according to the nonpartisan Center for Responsive Politics.


The Senate will take up a similar bill later this year. When it does, it needs to cure its many flaws, while also providing sufficient funds to the F.D.A. to meet its ever-increasing workload.

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21st Century Cures: Hide CME Payments & Allow Off-Label Promotion

21st Century Cures: Hide CME Payments & Allow Off-Label Promotion | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pharmas efforts to evolve restrictions about offlabel marketing move forward.


Although communication policy about medicines often moves slowly in Washington, two events last week portend advances not seen in decades.


You've no doubt heard about the overwhelming vote in favor of the 21st Century Cures bill, but you may have missed the drama in a New York federal courthouse early in the week. In Washington, the House of Representatives passed a historic medicines bill. In New York, the FDA weakly defended its off-label marketing policies and set up the judge to issue a likely order limiting the FDA's off-label enforcement.  


Taking the Cures bill first, the House voted 344-77 in favor of measures that promise faster cures to American patients by spurring research at the National Institutes of Health, speedier drug and device approvals at the FDA and more robust communication with industry and providers. The next step is the Senate, where the companion bill has thus far languished but will likely be taken up this fall in time for enactment later this year or early next.


Although largely ignored by the popular press, the bill's three communication provisions could well open the door to much more robust communication and marketing by our industries.  


First, the Physician Payment Sunshine Act provision sheds new light on shady interpretations by the Center for Medicare and Medicaid Services on education issues. The amendment, backed primarily by a coalition of medical societies, publishers and others coordinated by the Coalition for Healthcare Communication, was co-sponsored by Reps. Michael Burgess (R-TX) and Peter DeFazio (D-OR). Clarifying the original intent of the Sunshine Act, the provision would exempt from Sunshine-reporting certified CME events and the acceptance by doctors of medical reference texts and journal reprints.


Second, the payer-communication provision would significantly expand long-standing provisions that enable drug sponsors to talk openly with payers about some off-label issues, especially economic and comparative-effectiveness studies. This provision expands both the audience and the scope of the discussion, enabling discussion with “payers and similar entities” and increasing the range of studies that can be discussed.

Pharma Guy's insight:


A prior version of the bill included specific direction for FDA to issue clear guidance with respect to the use of the Internet and social media by industry, recognizing the heavy patient use – and even FDA’s use – of social media and its role in healthcare communications today. But that was dropped from the bill. No worries, Senator Long introduced a stand-alone bill that would force FDA to reverse it's stance and allow the "one-click rule" (if passed). For more on that, go here: http://sco.lt/5Jog8f 


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The 21st Century Cures Bill Jettison's "Gold Standard" for Approving Drugs

The 21st Century Cures Bill Jettison's "Gold Standard" for Approving Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Would a new Congressional bill designed to jumpstart medical innovation lower standards for approving new uses of existing medicines?


Consumer advocates are raising this concern about the 21st Century Cures legislation, which passed the House Energy and Commerce Committee unanimously last week and, in part, is designed to reform the approval process for drugs. Supporters say the bill is a long overdue move that, among other things, will give the FDA the tools to ensure treatments reach patients faster.


But critics say that a section of the bill devoted to drug development is problematic. Specifically, they point to language that would allow the FDA to approve additional uses for drugs without having to rely on randomized controlled trials. These are considered to be the gold standard for determining whether a medicine offers a benefit and help gauge the extent to which there are risky side effects.


The bill, however, pushes aside that evidence in favor of something called ‘clinical experience,’ which is defined as a mix of observational studies, patient registries and therapeutic use (see section 2062 on page 98). None of these, however, are viewed as scientifically rigorous for establishing whether a drug may be effective. Instead, critics say the language in the bill is sufficiently, perhaps deliberately, vague.


“Clinical experience is something that should be considered as additional information, but absolutely never take the place of scientific data,” says Diana Zuckerman, who heads the National Center for Health Research, a non-profit think tank. “By urging FDA to get away from randomized clinical trials, drug makers may have more power urge the FDA to consider data that is favorable to their product.”


“We don’t know what will happen,” says Thomas Moore, senior scientist at the Institute for Safe Medicine Practices, a non-profit that tracks drug safety issues. “Will it open the door to a wholesale reworking of clinical trial requirements? They are pushing the FDA to consider types of evidence that’s not been previously regarded as reliable enough.”

Pharma Guy's insight:


Also read: 21st Century Cures Act + Off-Label "Free Speech" = More Adverse Events, IMO http://sco.lt/8GUClV 

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Pharma Wants to Hide 26% of Payments It Makes to Docs - Welcome to 21st Century!

Pharma Wants to Hide 26% of Payments It Makes to Docs - Welcome to 21st Century! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Congress is now getting ready to pass the so-called 21st Century Cures Act. The draft bill, proposed bythe House Committee on Energy and Commerce, aims to foster medical innovation by streamlining the Food and Drug Administration's regulatory process and increasing National Institutes of Health research funding by $10 billion dollars. The draft, which has overwhelming bipartisan support, leads to many positive implications for patients, medical researchers and pharmaceutical companies.


However, the bill includes a passage which aims to amend a provision of the Physician Payments Sunshine Act, a law that requires drug companies to disclose their payments to individual physicians and teaching hospitals. The amendment would exempt pharmaceutical companies from reporting a major part of such payments that are made for continuing medical education or CME programs. The supporters of this change argue that physicians get to know about the latest developments in medical science through these programs, and requiring pharmaceutical companies to disclose such payments would discourage them from supporting the programs and ultimately inhibit medical innovation among doctors.


If we look at the data on these financial transactions, however, we get a much different picture. In the last five months of 2013, physicians who served as faculty or speakers on continuing medical education programs were paid more than $120 million dollars. The payments constitute 26 percent of the total financial transactions between pharma and individual physicians. The proposed change is essentially allowing pharmaceutical companies to hide more than a quarter of their payments to physicians.

Pharma Guy's insight:


For some of the biggest pharma companies, physician speaker fees may average as much as 43% of the total pimentos made to physicians. See my analysis here: http://bit.ly/1Ee3uzv 

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Rigid Inclusion/Exclusion Criteria Of Cancer Clinical Trials are Disgraceful & Unnecessary

Rigid Inclusion/Exclusion Criteria Of Cancer Clinical Trials are Disgraceful & Unnecessary | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Thousands of adult cancer patients with limited available treatment options are considered for clinical trials, but fewer than five percent are actually selected.

And that is a national disgrace. The 21st Century Cures Act, just signed into law by President Obama, supports the Vice President’s Cancer Moonshot, which identifies the low number  — less than five percent — of adult patients considered eligible for  cancer clinical research trials as one of the main  barriers to progress in the war against cancer. Compare this to the 60 percent of pediatric cancer patients who enroll in such studies. Why don’t adults appreciate the same imperative?
The fault lies not with our patients, but with those who design these studies. To maximize the likelihood of detecting clinically meaningful effects from the drugs being studied, trials seek fit, homogenous patient populations.

At first blush, this makes sense: investigators, and the Food and Drug Administration (FDA,) want to clearly define a drug’s safety and efficacy, and avoid erroneously attributing consequences of other medical conditions to the drug. It wouldn’t be fair, for example, in a patient with severe cardiac disease who experiences a heart attack while on a clinical trial, to say that this unfortunate event was unequivocally caused by a study drug.

As a consequence, many adults with cancer flunk the eligibility criteria that would allow them to join these trials, and the patients who are enrolled in these studies don’t truly reflect the U.S. population who will ultimately be treated by the approved drug.

Some in the field joke that a patient has to be an Olympic athlete to qualify for a study; but it’s no joke. Cancer clinical trial eligibility criteria are rigid — and recent research reveals that this is unnecessary.

 

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Further Reading:

Pharma Guy's insight:

The cancer moonshot coupled with easing of scientific evidence required for FDA approval, should lead to a flood of new cancer drugs that will not be effective, but will require more creative marketing (for more on that, read “21st Century Cures for Pharmaceutical Marketing”; http://bit.ly/2hEta4X).

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Pharma, Medical Device Industries Got an Early Christmas Present

Pharma, Medical Device Industries Got an Early Christmas Present | Pharmaguy's Insights Into Drug Industry News | Scoop.it

But Not Everything on Their List

Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

Note: Today, the U.S. Senate passed the 21st Century Cures Act. Last Wednesday, the U.S. House of Representatives passed the measure. See Public Citizen’s work surrounding the legislation – highlighting the serious impacts the bill will have on patient safety.

It is sorely disappointing that Congress gave Big Pharma and the medical device industry an early Christmas present by passing the 21st Century Cures Act. This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices.

However, because of the efforts of Public Citizen and allies, Big Pharma and medical device corporations did not receive all the goodies they put on their long wish list. Our pressure helped eliminate provisions that would have 1) opened a gaping hole in the Physician Payments Sunshine Act for educational gifts made by industry to physicians; 2) increased medication prices and cost taxpayers an estimated $12 billion over 10 years; 3) encouraged hospitals to overuse the newest antibiotics thereby contributing to the harmful spread of antibiotic resistance; and 4) allowed medical device manufacturers to make changes to high-risk medical devices without U.S. Food and Drug Administration oversight.

The bill passed today does less harm than the original bill that passed the House last summer, but Congress should not have had to jeopardize patient safety to increase medical research funding.

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21st Century Cures Bill Would Weaken the Sunshine Act Provision in the Affordable Care Act

21st Century Cures Bill Would Weaken the Sunshine Act Provision in the Affordable Care Act | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Tucked into the 21st Century Cures legislation that was negotiated by the House and Senate late last week is a controversial provision to exempt companies from reporting payments made to doctors for receiving continuing medical education sessions, medical journals, or textbooks.

 

The move — which has sparked objections from Senator Chuck Grassley (R-Iowa) — is the latest in a long-running attempt to roll back requirements for reporting such payments to a federal database that tracks financial relationships between companies and physicians.

 

Known as OpenPayments, the database was launched in 2014 in response to concerns that financial ties between drug and device makers and doctors may unduly influence medical practice and research. It was included in the Sunshine Act provision in the Affordable Care Act. As we noted previously, an analysis earlier this year found that payments can affect prescription rates.

 

Grassley, who was instrumental in pushing legislation that led to the database, may try to place a hold on the bill “unless this provision is removed,” he said in a statement. “The Sunshine Act brings transparency to a big part of the health care system for public benefit. Transparency brings accountability wherever it’s applied. With taxpayers and patients paying billions of dollars for prescription drugs and medical devices, and prices exploding, disclosure of company payments to doctors makes more sense than ever.”

 

Drug company payments have effect on prescription rates, analysis finds

Consumer groups are echoing this sentiment. “In a time of increasing concern about drug prices and spending, it would be unwise to reduce transparency about the financial relationships associated with drug promotion,” said Allan Coukell, senior director for health programs at the Pew Charitable Trusts (the language can be found in section 4009).

Pharma Guy's insight:

Massachusetts Senator Elizabeth Warren also objected to a provision that would allow drug companies to avoid disclosing fees paid to doctors for continuing medical education, medical journals, or textbooks. Warren tore into the package late yesterday on the Senate floor, saying “I will fight it because I know the difference between compromise and extortion.”

 

Related article: “21st Century Cures Bill Hides CME Payments & Allows Off-Label Promotion”; http://sco.lt/62vgQr

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Promoting Therapeutic Innovation: What Do We Do About Drug-Device Combinations?

Promoting Therapeutic Innovation: What Do We Do About Drug-Device Combinations? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Legislation proposed in the Senate, the Combination Product Regulatory Fairness Act, which is intended to promote innovation among products that contain both a drug and device (http://1.usa.gov/1KFLZg9).

 

The Combination Product Regulatory Fairness Act—introduced in July 2015—would broaden the ability for combination products to be classified as devices. The bill requires that jurisdiction as drugs or biologics not be assigned “solely because” of chemical action in the human body and orders the FDA to provide scientific support to the sponsor whenever the agency does not classify a combination product as a device.

 

In addition, the bill requires the FDA and sponsor to establish early in development a combination product review plan, an inflexible agreement on all aspects of clinical studies needed to establish its effectiveness and safety, including any postapproval studies. For example, if the FDA and sponsor agree on a clinical trial design that would test the product against placebo based on its effect on an intermediate outcome intended to predict clinical benefit or harm—a surrogate end point—the FDA would be highly restricted in its ability to later seek additional clinical data to inform its decision making.

 

However, the bill’s aims also put it at odds with certain important public health interests. The classification changes it proposes would inevitably increase the number of combination products reviewed under the more lenient 510(k) pathway, even though in 2014, almost two-thirds of combination products submitted for approval were already classified as devices (http://1.usa.gov/1KbpOUa). The 510(k) process provides important flexibility in making small alterations to moderate risk devices, but it has been criticized for being a highly limited premarket screen for a product’s safety and effectiveness and for permitting products to evolve substantially over time without adequate oversight, based on numerous seemingly innocuous updates (http://bit.ly/1SjUH9W). In addition, unlike for drugs and biologics, the FDA does not have authority to require postmarket studies as a condition of clearing a 510(k) device.

 

The bill’s restrictive combination product review plan compounds these potential negative patient safety implications. This proposed attempt to restrict FDA flexibility is reminiscent of a similar provision in the 21st Century Cures bill that limits the FDA’s ability to alter study plans for drugs in the accelerated approval pathway.

 

Balancing faster patient access to innovative agents with sufficient proof of the therapeutic product’s clinical benefit continues to be a difficult and dynamic process, but the FDA should not have to forfeit its current authority and flexibility in overseeing the development of therapeutic products before they reach patients. And patients and the medical community gain little from forcing more combination products to be classified as devices so that they can be sped to market with limited evidence of their safety and effectiveness.

Pharma Guy's insight:

Related articles: "99% of Medical Devices Approved by FDA with Shockingly Little or No New Research"; http://sco.lt/7W7p0D and "NYT Editorial: F.D.A. Won't Be Fixed by 21st Century Cures Bill"; http://sco.lt/6PLcGX and "Anecdotal Evidence Good Enough to Approve Medical Devices According to Lawmakers"; http://sco.lt/58AwLp 

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Pharma Guy's curator insight, March 31, 2016 6:11 AM

Related articles: "99% of Medical Devices Approved by FDA with Shockingly Little or No New Research"; http://sco.lt/7W7p0D and "NYT Editorial: F.D.A. Won't Be Fixed by 21st Century Cures Bill"; http://sco.lt/6PLcGX and "Anecdotal Evidence Good Enough to Approve Medical Devices According to Lawmakers"; http://sco.lt/58AwLp 

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99% of Medical Devices Approved by FDA with Shockingly Little or No New Research

99% of Medical Devices Approved by FDA with Shockingly Little or No New Research | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Even the devices that are studied the most probably aren't being studied enough.


Are federal regulators playing fast and loose with the health of the tens of millions of Americans who rely on medical devices to see, walk and survive? 


That's the suggestion of a new study that finds most medical devices go to market with little evidence that they work or are safe.


Groups like Consumer Reports and the Government Accountability Office have long criticized the U.S. Food and Drug Administration for approving medical devices that end up killing thousands of people a year. They've been most critical of the fact that the FDA allows 99 percent of new devices to go to market without any new clinical testing whatsoever.


But a team at the Yale School of Medicine found that even the 1 percent of devices that arestudied before getting FDA approval likely aren't being studied enough.


This 1 percent consists of so-called "high-risk" devices, which are very different from any others on the market and which are implanted within the body or directly support human life. The Yale researchers found that these devices are subjected to an average of just one major study apiece before being granted FDA approval. This means that doctors are implanting devices like coronary stents, replacement hips and intraocular lenses in thousands of patients after they've been tested on groups of just a couple hundred people each.

Pharma Guy's insight:

In contrast, of course, is the amount of evidence FDA requires to approve new drugs. But this may change -- for the worse -- if and when the 21st Century Cures Act is passed. For more on that, read " 21st Century Cures Act Could Weaken the F.D.A.’s Drug Approval Process"; http://sco.lt/6Z2OjR 


The Act would also make Anecdotal Evidence Good Enough to Approve Medical Devices; http://sco.lt/58AwLp 

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Anecdotal Evidence Good Enough to Approve Medical Devices According to Lawmakers

Anecdotal Evidence Good Enough to Approve Medical Devices According to Lawmakers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

THE Food and Drug Administration has been regulating the approval of medical devices since 1976, but its regulatory oversight has not kept pace with the increasing complexity of this technology. Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials). And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence (and the benchmark to which studies of drugs are held).


As a result, there have been many warnings about, and recalls and withdrawals of, medical devices that were found to be dangerous only after they were on the market. (In 2009, for example, the Sprint Fidelis defibrillator, which by that time had been implanted in hundreds of thousands of heart patients, was recalled because it frequently malfunctioned, harming many patients and leading to numerous deaths.) And because the F.D.A.’s oversight of medical devices once they are on the market is also weak, it is very likely that many malfunctions and other problems remain undetected.


Incredibly, legislation that the House of Representatives passed last week would severely weaken, not strengthen, the F.D.A.’s already ineffective regulatory scheme for medical devices. The device industry may stand to benefit from this legislation, but the health of the public does not. 


The legislation, disingenuously titled the 21st Century Cures Act, would make it possible for companies that produce high-risk medical devices to submit evidence of safety and efficacy based on sources other than clinical trials, including case histories (i.e., the experiences of individual patients). In other words, anecdotal evidence, rather than the scientific studies, could be used to approve devices.

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21st Century Cures Act Could Weaken the F.D.A.’s Drug Approval Process, Says Former FDA Commish Kessler

21st Century Cures Act Could Weaken the F.D.A.’s Drug Approval Process, Says Former FDA Commish Kessler | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The 21st Century Cures Act could substantially lower the standards for approval of many medical products, potentially placing patients at unnecessary risk.


For instance, the current version of the bill would allow consideration of drug approvals based on clinical experience, replacing scientific data from large numbers of patients in well-designed and controlled clinical trials.


Other provisions could mandate the use of biomarkers to approve a wider variety of drugs, far beyond just those for serious and life-threatening conditions.


Approval standards for medical devices, already lower than those for drugs, could become even less rigorous, allowing lifesaving devices like heart valves and stents to be revamped by manufacturers without the F.D.A. even reviewing the changes (though the agency would have to be notified).

Pharma Guy's insight:


Also read: 21st Century Cures Act + Off-Label "Free Speech" = More Adverse Events, IMO http://sco.lt/8GUClV

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#Pharma "Adamantly Refuses" to Help Fund 21st Century Cures Act

#Pharma "Adamantly Refuses" to Help Fund 21st Century Cures Act | Pharmaguy's Insights Into Drug Industry News | Scoop.it
The U.S. House Energy & Commerce Committee staff have asked the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) to offset some or all of the cost of the proposed 21st Century Cures Act, according to individuals involved in the discussions.

According to a report in BioCentury The trade associations adamantly refused to consider the proposal in a conversation with E&C staff this week.


A discussion draft of the legislation released last week included $10 billion over five years to create an “Innovation Fund” at NIH. The draft employed unusual language to bypass the standard funding process, avoiding the need for approval by House and Senate appropriations committees.
E&C Chairman Rep. Fred Upton (R-Mich.) has said the bill will be fully paid for, which means the committee will have to find revenue or savings to cover its costs and make the bill budget-neutral.


Industry objects to paying for the 21st Century Cures Act because companies feel the current discussion draft contains few provisions that would benefit them. Provisions in the first discussion draft that would have provided generous additional market exclusivity for many drugs were stripped out due to objections from Democrats.
Pharma Guy's insight:


Pharma may not be getting ALL that it wants from this legislation, but it seems it will get SOME of want it wants, namely modifying the Sunsshine Law so as not to have to report 26-43% of payments it makes to physicians. See http://sco.lt/74UMfB

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21st Century Cures Act + Off-Label "Free Speech" = More Adverse Events, IMHO

Congress is racing to produce a panacea for all that ails us—including nettlesome barriers to investment in the pharmaceutical and medical-device sector. The 21st Century Cures Act is rapidly moving through the House Energy and Commerce Committee with bipartisan support. It’s viewed by medical professionals as the most revolutionary change to the Food and Drug Administration’s approval process since the National Cancer Act in 1971, in which Congress and President Richard Nixon declared all-out war on that dread disease.


THE MOST IMPORTANT PROPOSAL in the House bill is the required emphasis on “biomarkers” by the FDA when it is determining the efficacy of a drug or therapy. This would encourage the agency to approve a product that works in a small group of patients sharing certain genetic traits. The current process requires medicines to work reliably among a larger, more general clinical-trial population in order to be approved.

Pharma Guy's insight:


IMHO, If FDA is authorized to approve drugs based on SMALL clinical trial data & for limited use matched to a patient's genotype AND if the FDA cannot limit off-label promotion (i.e., it loses the Amarin case; http://sco.lt/90Sefp) then OTHER small trials can be used to support the "off-label" use of the drugs in a larger population. The net result may be more drugs on the market for which safety data is lacking -- data that shows up in larger trials but not small ones.

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