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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HHS Tweet Touts the Trump Administration’s “Accomplishments” Like Its “Sham” Response to the Opioid Crisis, Withdrawing Regulations, and Cutting Open Enrollment Budget by 90%!

HHS Tweet Touts the Trump Administration’s “Accomplishments” Like Its “Sham” Response to the Opioid Crisis, Withdrawing Regulations, and Cutting Open Enrollment Budget by 90%! | Pharmaguy's Insights Into Drug Industry News |

A new report released by the Department of Health and Human Services highlights the greatest hits of the Trump administration in 2017.


Among the highlights touted: efforts to identify federal regulatory burdens that hurt patients, as well as ways to lower high prescription drug costs. The result, the report said, was a “net decrease in the burden imposed by HHS regulations as well as positive reforms in a range of Medicare payment rules, actions from the Food and Drug Administration, and ongoing reviews of further areas for action.”


Regulatory rollbacks

To reduce burdensome regulations, the report notes that HHS withdrew 70 regulatory actions taken by the Obama administration, took 68 deregulatory actions and only introduced 27 regulations. In addition, CMS Administrator Seema Verma went on a listening tour to talk to providers, doctors and clinicians about regulatory burdens.


Open enrollment cutbacks

But many of the accomplishments listed in the report were controversial. For example, HHS says it conducted a “successful, consumer-friendly open enrollment period at significantly lower cost than in previous years, attracting similar levels of enrollment with more focused investments in marketing:” Yet the enrollment numbers are generally credited to the fact that private insurers stepped up advertising efforts to compensate for the fact that the federal government cut its ad budget by 90% and the amount of time citizens had to enroll in plans.


Response to opioid crisis

The report is also proud of the administration’s work to combat the opioid crisis in the U.S., citing Trump’s declaration that the epidemic was a national public health emergency and raising public awareness to the issue. But the response has been criticized by many who note that without funding, the declaration was meaningless. Last week former Democratic Rep. Patrick Kennedy, one of six members appointed to a bipartisan commission in March by President Trump to address the opioid crisis, called the work done by the task force a sham because the administration hasn’t put any money behind the actions the group suggested to combat the epidemic (

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A Deeper Look at FDA's 2015 Enforcement of Drug Promotions

A Deeper Look at FDA's 2015 Enforcement of Drug Promotions | Pharmaguy's Insights Into Drug Industry News |

As mentioned in a previous post, the FDA issued the fewest ever enforcement letters regarding Rx drug promotions (read "2015 Was Another Good Year for Orphan Drugs & Pharma Marketers").

Of the 9 letters FDA sent to drug companies regarding violations, 2 were serious "Warning Letters" and 7 were "Untitled Letters." The following chart shows the Warning vs. Untitled letter trend from 2010 through 2015.

One Warning Letter went to Duchesnay for the promotion of Diclegis via Instagram. FDA cited 2 violations: (1) Omission of Risk Information (see "OMG. Kim Kardashian Shills for Pharma! No Worry - No Side Effects!") and (2) Omission of Material Fact (the post failed to provide material information regarding DICLEGIS’ full approved indication, including important limitations of use). The other Warning Letter went to a Valeant subsidiary for the promotion of Tussicaps. FDA cited 3 violations: (1) Omission of Risk Information, (2) Inadequate Communication of Indication, and (3) Unsubstantiated Claims.

Deeper analysis reveals which violations reigned supreme. See it here.

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Big Pharma Pushes for Off-Label Promotion

Big Pharma Pushes for Off-Label Promotion | Pharmaguy's Insights Into Drug Industry News |

Should a pharmaceutical sales rep be allowed to tell a doctor that Topamax, a drug approved to treat seizures and prevent migraine headaches, might also help combat alcohol dependence? Or suggest the epilepsy drug Neurontin could also help treat bipolar disorders or insomnia? Or offer data showing that any number of other drugs could have uses beyond those listed on their labels?

For decades, the answer overwhelmingly has been no. The Justice Department has aggressively pursued companies that run afoul of rules against such “off-label” marketing — racking up billions of dollars in settlements. And the Food and Drug Administration has held firm to the idea that sales pitches generally should not include information on uses not approved by the agency.

But in the long-running conflict between federal regulators and drugmakers over how companies promote their drugs for unapproved uses, the landscape could be shifting, if only in subtle ways, and the outcome could affect doctors and patients alike.

Prompted in part by recent federal court decisions, the FDA is reviewing its rules on what kind of data drug companies should be allowed to distribute to doctors regarding off-label uses, as well as how they should respond to unsolicited questions from physicians about those uses. Its goal is to issue new guidelines by the end of the year.

Critics of the current rules say allowing pharmaceutical companies, which know the most about their drugs, to share more information about off-label uses would lead to better-informed physicians and ultimately benefit patients. Others are skeptical, saying the industry could exploit even a minor loosening of the restrictions to hype drugs for unapproved uses, exposing patients to ineffective and potentially harmful treatments.

Pharma Guy's insight:

Some industry officials say the FDA has been slow to adjust to the reality of those court rulings.

“They were in denial,” said John Kamp, executive director of the Coalition for Healthcare Communication, which represents drug marketing agencies and medical publishers. “If doctors can talk to each other and major researchers can talk about off-label uses, the drug’s manufacturer should be able to talk about those uses, too.. . . If something is true and can be said by one party, it can be said by all other parties.”

 Aaron Kesselheim, a Harvard Medical School professor who has studied off-label promotion, asks: Who gets to decide what qualifies as “truthful” information when it comes to sharing data about unapproved drug uses?

What do you think? SURVEY: Distribution of Off-Label Reprints by Pharma: Are FDA's New Revised "Rules" Too Limiting?

Pharma Marketing Blog post: 

WLF to FDA Regarding Distribution of Off-Label Reprints: See You in Court!
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FDA Regulators Can't Scale To Police Mobile Health Apps

FDA Regulators Can't Scale To Police Mobile Health Apps | Pharmaguy's Insights Into Drug Industry News |
A senior advisor to the FDA said the agency couldn't possibly scale up to meet the challenge of policing the hundreds of new apps appearing every month.

The sheer pace of innovation in the mobile health application space and the numbers of such applications already available on mobile marketplaces like the iTunes App Store and Google Play mean that many mobile health applications will escape scrutiny by federal regulators, said Bakul Patel, a Policy Advisor in the FDA’s Center for Devices and Radiological Health.

Pharma Guy's insight:

Will It Be FDA Regulation or Self-Regulation or Both?

In the early days of the Internet hundreds of health Web sites of questionable quality proliferated without any guarantee of accuracy, lack of bias, privacy, etc. Today, thousands of mobile health apps of unknown quality are available for downloading by healthcare professionals and consumers.

As with Web sites in the early days, it is difficult today for users of mobile health apps to be assured that the apps are reliable, accurate, based on valid information, and adequately safeguard users' information. In many ways, we are living through another digital "wild west" without any sheriffs to protect us.

And it appears that we do need protection. 

Topics include:

  • Inaccurate Health Apps
  • Overzealous FDA Regulation?
  • The Regulation of Pharma Health Apps Survey Results
  • Good App Privacy Practices
  • Test and Document
  • Possibly the First Ever "Dear Doctor' Letter Regarding a Recall Mobile Medical App
  • Certification of Mobile Health Apps
  • Will Regulation Kill Innovation?
  • Self-Regulation: Devil's in the Details

Read this article now. It's FREE...

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FDA requires more warnings on testosterone products

FDA requires more warnings on testosterone products | Pharmaguy's Insights Into Drug Industry News |

The U.S. Food and Drug Administration (FDA) is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products.

Because these clots occur in the veins, this new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. We are currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in the Drug Safety Communication posted on January 31, 2014.

Testosterone products are FDA-approved for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone for reasons such as genetic problems or chemotherapy.

Pharma Guy's insight:

In February, 2014, Public Citizen today called on the U.S. Food and Drug Administration (FDA) to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S. 


Public Citizen Petitions FDA to Add a Black Box Warning to Low-T Drug Labeling

A pharma compliance executive -- who shall remain anonymous -- emailed me saying: "Great to know that OPDP got their [Twitter] guidance out in time to make clear that no testosterone manufacturer should be able to tweet about the new warning."

That brings up an interesting point. 

If a pharma company-- e.g., AbbVie, which markets Androgel -- wishes to tweet about this emerging risk, would the tweet be considered promotional by the FDA? For example, the tweet can mention the product name WITHOUT the indication and warn about this issue and link to more information (e.g., the FDA notice). At most, that tweet would be considered a "reminder" ad and would not be subject to the new guidelines published by OPDP.

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The FDA Social Media Guidances May Not Change Anything: Senak Explains

The FDA Social Media Guidances May Not Change Anything: Senak Explains | Pharmaguy's Insights Into Drug Industry News |
After a five-year wait, the FDA this week released guidelines for how drug and device makers should deal with social media. One provides a blueprint for correcting misinformation on websites run by others, while the second guidance discusses the use of Twitter. We spoke with Mark Senak, a senior vice president and partner at the FleishmanHillard public relations firm that works closely with drug makers and who also writes the Eye On FDA blog, about what the guidances may – or may not - change.

Pharmalot: And what about the other guidance, which refers to using Twitter?

Senak: Using Twitter for specific product communications prior to the guidance was problematic because there were so many unknowns. But now it’s problematic because of what we know.

Pharmalot: What do you mean?

Senak: In general, the manufacturer must present risk information in the same venue as any discussion of a product. In characters placed in a limited venue, people didn’t know how to cram all of that into 140 characters, particularly after the banishment of a one-click rule in 2009, [my emphasis] when you couldn’t use a link to take you elsewhere to read the info.

So people avoided Twitter, because it wasn’t known how to satisfy requirements. Looking at the guidance and the example of how to develop a Tweet, it’s still so constricted that I think product-specific communication by Twitter is still problematic. Again, I think it’s a situation where not much has changed.

Pharma Guy's insight:

I take issue with Senak's statement that the "one-click rule" was "banished" by the FDA in 2009. He's referring to the famous 14 letters FDA sent to major drug companies on April 2, 2009 (read "Ramifications of FDA Regulatory Actions").

Here's what I wrote in November 2007 - nearly one and one-half years prior to when Senak says FDA "banished" the one-click rule (read: The "One-Click Rule": Rant or No Rant?):

The "one-click rule" is no rule at all and is merely a platitude online pharmaceutical marketers spout to trick us into believing that they obey "rules." Since I spend a lot of time documenting how pharma marketers violate this "rule" repeatedly, I thought I would write a comment to the authors of a document that advised pharma about the "rule." Here it is. You decide if it is a "rant" or not.

In the paper, the authors make frequent reference to the so-called "one-click rule" regarding access to fair balance information on the Internet.

If you search Google on "one-click rule FDA" you won't find any references to this rule that the FDA has made, but you will find my post "Girl from Google." (posted in November 2005).

That's because, in that post, I discuss how the so-called "one-click rule" was used to justify Google Adwords (aka, "BAdwords") that violate FDA guidelines -- these ads mention the brand name and indication, but do NOT include any fair balance as is required by FDA. (NOTE: THE FDA'S 14 LETTERS PRECISELY TARGETED THESE KINDS OF ADS IN APRIL, 2009, MORE THAN 2 YEARS AFTER I POINTED OUT THAT THESE ADS VIOLATED FDA REGULATIONS!).

One person from a pharmaceutical company, perhaps playing the devil's advocate, contended that these "BAdword" ads may pass muster with the FDA because the package insert or brief summary is "one or two clicks away." His argument was that without specific guidance from the FDA, no one knows what is correct in this case.

It is a shame that the FDA does not have any guidance for the industry as far as Internet advertising is concerned. This means that marketers can use lack of guidance as a defense for sneaking in ads that push the envelope. What are the chances that the FDA would ever notice (BUT THEY DID!). These ads are fleeting, here today, gone tomorrow!


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Pharma to FDA: "We're Here to Help" You Vet Off-Label Information

Pharma to FDA: "We're Here to Help" You Vet Off-Label Information | Pharmaguy's Insights Into Drug Industry News |
Should an independent entity review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors?


Drug makers have long argued that the Food and Drug Administration is squelching their free speech rights by barring off-label promotion of their medicines. A new proposal may give them a voice.


This month, a think tank at Duke University called ( for a new independent entity to review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors.


Companies say current regulations prevent them from distributing important data to physicians about unapproved, off-label uses of their medicines. The FDA worries public health can be compromised if marketing claims aren’t backed up by solid evidence. A neutral third party, the authors of the white paper say, could provide much-needed arbitration.


“There’s a lot of accurate and scientifically robust information that can be shared,” said Peter Pitts, a former FDA official who now heads the Center for Medicine in the Public Interest and is one of the authors of the proposal. “But the FDA can’t be expected to review everything itself.”


That’s true. The agency does have limited resources. But the real issue is whether an independent body would, ultimately, undermine FDA authority and serve as a marketing tool as much as anything else.


Industry critics have long worried companies are looking for ways to distribute promotional fluff. And such concerns divided the working group at the Duke-Margolis Center for Health Policy, which hosted a conference two weeks ago where the paper was issued and discussed (watch session one and two).


“I think this proposal is asking the wrong question,” said Dr. Joshua Sharfstein, a former deputy FDA commissioner and an associate dean at the Johns Hopkins Bloomberg School of Public Health, who did not help write the proposal.


“I fear this is all about asking how we can allow companies to promote as much as possible,” he said. “Instead, we should be asking: How can we create the correct incentives so that good research is done and we get the best information to distribute?”

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Effect of PDUFA fees on FDA's drug approval process & regulation of approved drugs.

Effect of PDUFA fees on FDA's drug approval process & regulation of approved drugs. | Pharmaguy's Insights Into Drug Industry News |

A new study by researchers from Cambridge Health Alliance/Harvard Medical School, Boston Medical Center (BMC)/Boston University School of Medicine (BUSM), City University of New York School of Public Health, and Public Citizen, reveals that drugs released after the 1992 enactment of the Prescription Drug User Fee Act (PDUFA), which allowed the FDA to collect fees to expedite drug approvals, were more likely to be withdrawn or have a black box warning.

In recent years, the number of warning letters issued by the FDA regarding Rx drugs has dramatically decreased. Some experts claim that this is due to fewer drugs being approved and marketed. However, is it possible that the rise in PDUFA payments -- which now account for about 65% of FDA's budget for regulation of drugs -- discourages the FDA from monitoring drug promotion and issuing warning letters?

Pharma Guy's insight:


It could be argued that even as PDUFA fees increased dramatically after 2001/2002, the number of warning letters issued remained pretty flat, which indicates PDUFA had no effect.


In 2001 FDA's Chief Counsel at the time was Bush-appointed Daniel E. Troy, who instituted a legal review of regulatory letters before they were issued and this policy change effectively hobbled the issuance of these letters by the FDA. Hence, fewer warning letters beginning in 2001/2.

The Government Accounting Office (GAO) submitted testimony that documented, among other things, how long it took the FDA to issue regulatory letters citing violative DTC materials during Troy's reign. 


For more on this, read: 

FDA DTC Review: The House that Troy Built

Joel Finkle's curator insight, August 6, 2014 10:09 AM

Do PDUFA fees lead to approvals of unsafe drugs? The chart would appear to refute that.

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FDASIA Deadline UpDate: "Nearly All" Deliverables Completed, Says FDA

FDASIA Deadline UpDate: "Nearly All" Deliverables Completed, Says FDA | Pharmaguy's Insights Into Drug Industry News |

From Margaret A. Hamburg, M.D.

Anniversaries are a time for stock-taking and today, on the second anniversary of the Food and Drug Administration Safety and Innovation Act or FDASIA, I’m pleased to report on the progress we’ve made implementing this multi-faceted law.

To date, we have completed nearly all of the deliverables we had scheduled for the first two years after FDASIA became law. And many of the new authorities under FDASIA are already having a positive impact on health. It’s difficult to cover all of our FDASIA work, but here are some highlights:

Pharma Guy's insight:

One deliverable not "completed" and not mentioned by Dr. Hamburg is the one remaining piece of social media guidance FDA promised to deliver in 2014. Find more on that here.

Joel Finkle's curator insight, July 11, 2014 9:31 AM

FDA scores itself on their FDASIA achievements. I don't have any nitpicks, as the things I want (RPS, IDMP documentation) are all further out and dependent on external organizations.

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"Heavy regulation makes healthcare a painful business," Says Google's Brin

"Heavy regulation makes healthcare a painful business," Says Google's Brin | Pharmaguy's Insights Into Drug Industry News |

The heavily regulated healthcare technology environment makes it a difficult business to pursue, according to Google's two co-founders, but they remain entranced by its possibilities.

"Generally, health is just so heavily regulated. It's just a painful business to be in," Sergey Brin told technology venture capitalist Vinod Khosla, adding: "I think the regulatory burden in the US is so high that think it would dissuade a lot of entrepreneurs.

Pharma Guy's insight:

But Brin said he was very excited about Google's glucose reading contact lenses, which "should be coming along pretty well".

I'm not surprised by Brin's comments. Google and the Brin family (including the Mrs. - Anne Wojcicki) have had run-ins with the FDA.  Google, for example, settled a U.S. criminal investigation into allegations it made hundreds of millions of dollars by accepting ads from online pharmacies that break U.S. laws (see "How FDA, in Cahoots with DOJ, Brought Google Down"). That's a serious felonious offense, yet nobody from Google went to jail!

And Mrs. Brin was caught trying to sell a genetic test kit with unproven accuracy. She just decided to ignore all of FDA's many inquiries until FDA had no choice but to shut down her business, at least temporarily (see "FDA Orders 23andMe to Immediately Discontinue Marketing "Spit for Cancer" Kit"). Even then, she remained defiant to the point where one wonders if wealth gives her the feeling of superiority uber alles. Nowadays, however, she is greasing the wheels with her wealth to get the FDA more in line with her business plan. Now, that wasn't so painful, Anne, was it?

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Thinking Outside the Tweet

Thinking Outside the Tweet | Pharmaguy's Insights Into Drug Industry News |

I couldn't sleep last night. For some reason I became obsessed with trying to figure out a way that pharma companies can create Rx branded tweets that satisfy FDA's recent "Industry Guidance for Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices."

Pharma Guy's insight:

"The draft guidance does not mention Tweets accompanied by images, which is perhaps a way to present ISI along with benefit information in the tweet itself," I said. "I have created a mock-up using Lipitor as an example."

Here's a screen shot of how this tweet would look on Twitter (would it pass muster with FDA? Tell me your opinion on Pharma Marketing Blog).

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FDA Finally Proposes Social Media Guidelines

FDA Finally Proposes Social Media Guidelines | Pharmaguy's Insights Into Drug Industry News |
After several years of anticipation, the FDA has finally proposed a pair of guidelines for how drug and device makers should cope with some of the challenges and pitfalls posed by social media.

One of the so-called draft guidances offers instructions on how companies should attempt to correct product information on websites that are run by others, such as chat rooms. The otheraddresses how products – including risk and benefit information – can be discussed in venues such as Twitter, as well as paid search links on Google and Yahoo, all of which have limited space. This will involve using links to product web sites, for instances, that can be clicked.

“These are intended to have a beneficial impact on public health,” Tom Abrams, who heads the FDA Office of Prescription Drug Promotion, tells us. “But these were not developed in a vacuum. They were developed with careful consideration and with input from industry and many other stakeholders. There was a lot of important consideration given to the issues.”

For third-party websites, suchas Wikipedia, the draft guidance suggests that companies should feel free to correct misinformation, but that any correction must include balanced information and the source of the revision or update must be noted, Abrams explains. This means a company or company employee or contractor should be credited with any additions.

“The information should not be promotional and should be factually correct. This is not an opportunity for a company to tout its drugs,” he says. “The information [being added or revised] should be consistent with the FDA-approved [product] labeling and for it to be effective, you want it posted right by the misinformation.”

The guidance also says that companies should contact writers, such as bloggers, to make changes when they learn of misinformation. Abrams notes companies will not be held responsible for those who do not make changes. If none of this is possible, he says companies should contact web site operators and suggest they delete the misinformation or open the site to comments so that corrections can be made.

Pharma Guy's insight:

Well, well, well. I can't believe it! And I thought FDA would miss the July 2014 deadline imposed by Congress. For more on that, read: Will FDA Avoid the "Social Media Guidance Cliff"?

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