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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Why Is FDA Issuing Fewer Marketing Violation Letters? Follow the Money!

Why Is FDA Issuing Fewer Marketing Violation Letters? Follow the Money! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

As mentioned in a previous Pharma Marketing Blog post, the FDA's Office of Prescription Drug Promotion (OPDP) issued the fewest ever enforcement letters regarding non-biologic Rx drug promotions in 2015 (read "2015 Was Another Good Year for Orphan Drugs & Pharma Marketers").


Mark Senak - who works for the public relations firm Fleishman-Hillard and who writes EyeOnFDA blog - suggested a couple of theories as to why OPDP is issuing fewer warning letters these days.


But I can trump that with a totally different theory based on the tried and true investigative journalistic axiom; i.e., "Follow the Money."


More about that here...



Pharma Guy's insight:

A simple theory.

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9, 10 Reasons Why FDA Is Approving Every Drug It Sees

9, 10 Reasons Why FDA Is Approving Every Drug It Sees | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Last week I [Matthew Herper] wrote a post about new data from BioMedTracker that show that the Food and Drug Administration, which once approved as few as 40% of new drugs submitted by industry, has been on a green-light-almost-everything jag, approving 89% of drug applications.


What’s more, a closer look showed an even higher approval rate. This year so far, 96% of new molecular entities– industry jargon for drugs that have never been approved for any use before – that have been submitted to the FDA have reached the market. For anyone who was watching the FDA a decade ago, that’s just shocking. Good or bad, it’s a radical change.


It’s certainly true that there are a lot of factors that explain why the FDA approval rate is suddenly so high, and I only gave them a few paragraphs in the last piece. So here I’ll list nine (see pharmaguy's #10 in the comment section):


  1. The approval rate is much lower, because only 12% of drugs that enter clinical trials reach the market
  2. Drug companies are better at research, and they are simply producing better drugs
  3. Drug companies are picking areas where the chances of approval are higher
  4. The FDA is doing a better job communicating with companies ["and vice versa," says pharmaguy]
  5. The FDA has more power to restrict the use of an approved drug than it used to
  6. The FDA is taking a risk by taking strong stands against drug approvals right now
  7. The FDA is without a permanent commissioner
  8. It’s just random chance
  9. In the current political environment, the agency is approving drugs it shouldn’t


Pharma Guy's insight:

#10: It's no coincidence that this is happening as FDA sets its sights on PDUFA VI reauthorization: http://sco.lt/5nZ3p3

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FDA Sets Its Sights on PDUFA VI Reauthorization

FDA Sets Its Sights on PDUFA VI Reauthorization | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Prescription Drug User Fee Act (PDUFA) authorizes FDA to collect fees from pharmaceutical companies to help fund the agency’s drug review work. PDUFA’s intent is to provide additional funding for FDA to hire staff, improve systems, and establish a better-managed review process that enables us to do more timely reviews of human drug applications.


As part of FDA’s agreement with industry during each reauthorization of the Act, the agency agrees to certain performance goals to enhance the process of drug review. The goals, now 30 in total, apply to many review processes, including the review of original new drug applications, resubmissions, and supplemental applications. Since the first user fee law was passed in 1992, PDUFA has been reauthorized four times. The current legislation, PDUFA V, is set to expire in September 2017.


On July 15, 2015, FDA gathered stakeholder perspectives during a meeting on what features the agency should propose in the reauthorization of PDUFA for fiscal years 2018 – 2022. Attendees included patient advocates, consumer advocates, representatives of professional health care associations, biopharmaceutical industry representatives, academic researchers, policy analysts, and others. FDA received mostly positive feedback on our progress under PDUFA V and helpful input about the future for PDUFA VI.


Highlights of progress noted during this meeting include:


  • FDA continues to meet or exceed most review goals.
  • The program is experiencing high rates of approvals for novel products during their first submission. This includes a historically high number of approvals for novel products treating rare diseases (17 orphan drug approvals in 2014).
  • There are improved and increased communication functions and practices between FDA and new drug companies, or sponsors. This includes implementation of a structured risk-benefit framework within the review process.
  • The Patient-Focused Drug Development program has been successful in systematically obtaining patient perspectives on certain diseases and related treatments.


Meeting participants also contributed a number of ideas for further enhancements, including:


  • Further efforts to involve the patient perspective in drug development processes;
  • Building on FDA’s Sentinel System for active surveillance of safety issues for medical products, including expanding its use as a source of data; and
  • Enhancing regulatory science initiatives, including the use of patient-reported outcomes and biomarkers.


More detailed information about the meeting is available at PDUFA Meetings, which includes a webcast of the one-day meeting, the agenda, access to the docket for online public comments, and (soon to follow) a complete written transcript of the public meeting’s proceedings.



Pharma Guy's insight:

It's no coincidence that FDA's drug approval rate is at an all-time high: http://sco.lt/5BKg6r 

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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 | Scoop.it

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

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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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Did FDA Avoid the "Social Media Guidance Cliff"?

Did FDA Avoid the "Social Media Guidance Cliff"? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Section 1121 of the Prescription Drug User Fee Act (PDUFA) states: "Not later than 2 years after the date of enactment [signed into law on 9-July-2012], FDA shall issue guidance describing FDA policy regarding Internet promotion, including social media, of medical products regulated by FDA" (see here). 

I call this the "Social Media Guidance Cliff."

Pharma Guy's insight:


Well, today is exactly two years after PDUFA V was signed into law. While FDA has issued a few social media guidance documents, it still has one more to go: Use of Links


FDA's "Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2014," which was published in January 2014, promised that it would publish that guidance sometime in 2014 (see here).


Section 1121 was not specific as to how many social media guidances FDA should issue before toddy's deadline. So I guess FDA is off the hook as far as complying with section 1121 is concerned.

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The Power and the “Science” of Patient Input

The Power and the “Science” of Patient Input | Pharmaguy's Insights Into Drug Industry News | Scoop.it
FDA And Pharmaceutical Companies Welcome Patient Voices To New Drug Development –- But Will It Last?
Drug companies and industry regulators welcome patients' opinions more than ever before, but wading through the flood of information can be a challenge.


Many stakeholders from health policy experts to physicians to patients’ groups are broadly in support of this shift. But the U.S. Food and Drug Administration isn’t quite sure how to handle the resulting flood of information, anecdotes and opinions that comes from a patient-centered focus. As a result, there is ambiguity about if and how patients’ feedback will be incorporated into the process by which new medicines progress from an idea in a lab to a finished product on the shelf.

In particular, the FDA offers little guidance on how so-called “patient-focused outcomes” might be used to support a new treatment proposed by a drug company, or whether such results eventually could be published on a label next to side effects. Companies eagerly have echoed the FDA’s patient-centric mindset, but without clear instructions on how to standardize and incorporate patient opinions it may be difficult to translate that enthusiasm into better medicines or higher sales.

“I believe the whole patient-centric movement really signals a pretty profound change but I also have this fear that if we don't implement this correctly, we'll lose our patience,” said Ken Getz, director of sponsored research at Tufts Center for the Study of Drug Development.


Meanwhile, the FDA is working to renew the Prescription Drug User Fee Act (PDUFA), which permits the agency to collect user fees from major drug companies. It could use these funds to develop meaningful ways to incorporate patient opinions into clinical trials and eventually product labels -- a move requested by the industry group Pharmaceutical Research and Manufacturers of America (PhRMA) during a public comment period that ended Monday.


“We have heard from pharma and bio that -- and they’re using the term ‘science of patient input’ -- is one of the most important items of discussion for the reauthorization of PDUFA,” said Theresa Mullin, director of the Office of Strategic Programs at the FDA Center for Drug Evaluation and Research. “They're identifying this as a high-priority area.”

Pharma Guy's insight:

The power, if not the science, of patient input was a major factor in the approval of Addyi, even before PDUFA was renewed. Read this comment in the Federal Register:  http://1.usa.gov/1OgqViE 

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FDA's Unbridled 96% New Drug Approval Rate: A New Record!

FDA's Unbridled 96% New Drug Approval Rate: A New Record! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Remember when the FDA rejected drugs?


We just got treated to a whole lot of drama this week as to whether Addyi, a drug to boost women’s libidos, would be approved. But based on the data, that approval was probably a foregone conclusion.


As recently as 2008, companies filing applications to sell never-before-marketed drugs, which are referred to by the FDA as “new molecular entities,” faced rejection 66% of the time. Yet so far this year the FDA has rejected only three uses for new chemical entities, and approved 25, an approval rate of 89%.


In reality, the FDA approval rate is more like 96%. Eliminating BioMedTrackers counting of multiple uses for the same drug means FDA approved 23 drugs and rejected 1, Merck ’s anesthesia antidote, Bridion. Again, that means 19 of 20 new drug applications were approved.

Pharma Guy's insight:

It's no coincidence that this is happening as FDA sets its sights on PDUFA VI reauthorization: http://sco.lt/5nZ3p3

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FDA's 2014 Scorecard: Drug Approvals Up, Advertising Enforcement Actions Down!

FDA's 2014 Scorecard: Drug Approvals Up, Advertising Enforcement Actions Down! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In 2014, the FDA approved 41 new drugs -- the most since 1996 (see here). That's quite a "record" even if 37% of the approvals were made in December alone.

But FDA wasn't as anxious to set any advertising enforcement records in 2014. The Agency sent out only a meager 9 Untitled Letters and 1 Warning Letter last year (see chart on left).

Could the reason for this be that pharmaceutical marketers are getting better at complying with FDA regulations?

Or is the FDA afraid of being sued by the pharmaceutical industry in the wake of the 2012 Caronia decision in the U.S. Second Circuit that found off-label promotion was protected by free speech?

Or perhaps FDA depends more and more on "user fees" paid by the drug industry and does not want to "bite the hand that feeds it"?

I think the latter is the most likely explanation. Read on to learn why.

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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 | Scoop.it

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.


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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.