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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2016 Sees a Slight Uptick in FDA Enforcement Actions

2016 Sees a Slight Uptick in FDA Enforcement Actions | Pharmaguy's Insights Into Drug Industry News | Scoop.it

UPDATED 15 December 2016: A few days ago, I reported that FDA continues to issue fewer and fewer warning and untitled letters. When I wrote that (8 December 2016) FDA had issued only 5 enforcement letters (4 untitled and 1 warning letter) compared to 9 letters in 2015.

 

This week on 12 and 13 December, FDA issued 4 new letters - 2 warning letters and 2 untitled letters - to bring the total to 9 letters for 2016. As the revised chart on the left shows, this equals the number of total letters FDA sent last year but this year, to date, FDA issued one more warning letter than it did last year. So, this could be considered a "slight uptick" in enforcement actions since warning letters are more serious than untitled letters, although the additional warning letter involved the promotion of a surgical irrigation solution promoted by United-Guardian via email to healthcare professionals.

 

Perhaps FDA is clearing its backlog and approving letters to be sent before the Trump regime takes over. That is, if Trump has his way and Silicon Valley investor Jim O’Neill becomes the new FDA Commissioner.

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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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FDA Continues to Ease Off on Issuing Warning and NOV Letters

FDA Continues to Ease Off on Issuing Warning and NOV Letters | Pharmaguy's Insights Into Drug Industry News | Scoop.it

During the first quarter of 2015, not only were there few letters, there were few violations cited within these letters. Many times a letter will contain multiple violations, but this quarter the three letters cite  a total of only seven violations. During the first quarter of 2014, OPDP had produced only two letters – also covering seven violations and in 2013 there were only three letters covering nine violations. By contrast, the first quarter of 2012 saw eight letters with nineteen violations.


Also notable was the type of violations – Since tracking and reporting on the letters here at Eye on FDA, the most common violation has consistently and overwhelmingly been the Omission or Minimization of Risk, but this quarter, it was cited only once.


Other than the fact that there were so few letters and so few violations, this quarter was also notable for the fact that one letter contained four of the violations. Another notable aspect was the fact that one of the violations was for Promotion of an Investigational Compound, which is a relatively rare violation. In this letter, the agency cited numerous statements made on a web site that stated that the product was “easy and safe” among other things. Finally, the final of the three letters from this quarter provided an example where it the agency cited a company when it emphasized the fact that it was the only synthetic alternative to animal-based products which inferred superiority.


The lack of activity related to enforcement by OPDP unfortunately leaves less insight into the agency’s thinking around evolving issues, particularly in the area of digital media where guidance has been so long in coming and short on substance.

Pharma Guy's insight:


Last year, the agency sent out only a meager 10 advertising enforcement letters, the fewest ever: http://bit.ly/pmn140103

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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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Have Hefty DOJ Fines Made Pharma Marketers More Compliant with FDA Regulations?

Have Hefty DOJ Fines Made Pharma Marketers More Compliant with FDA Regulations? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Is the number of warning letters low because pharmaceutical marketers have learned to be more compliant with FDA regulations or is there some other reason?


Could it be that pharma marketers have become more compliant with FDA regulations because their MLR people became more assertive after many major pharma companies, which do a lot of drug marketing, were fined billions of dollars for inappropriately, and in some cases illegally, promoting prescription drugs?

Pharma Guy's insight:


DOJ fines are much more persuasive than "slap on the wrist" notice of violation letters from the FDA. As they say, "money talks, nobody walks." 

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Pharma Guy's curator insight, March 31, 2016 11:25 AM

 

DOJ fines are much more persuasive than "slap on the wrist" notice of violation letters from the FDA. As they say, "money talks, nobody walks." 

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John Kamp Says 2016 Will Bring More Warning Letters From FDA. Bull or No Bull?

John Kamp Says 2016 Will Bring More Warning Letters From FDA. Bull or No Bull? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

John Kamp, Executive Director of the Coalition for Healthcare Communication, said in an MM&M piece that "2016 may bring more warning letters, guidance from FDA."


As it was designed to do, that headline caught my attention.


"There is a virtual revolution at the FDA in drug marketing enforcement," said Kamp. "The revolution is driven mostly by recent First Amendment challenges to drug communication regulation, especially the Supreme Court's IMS Health decision in 2012, the Caronia federal appeals decision in 2014 and the FDA loss in the Amarin case this past summer.

The turning point, though, was an FDA court settlement with Pacira Pharmaceuticals in December, in which the FDA reversed course and reaffirmed broad indications for Pacira's non-opioid pain medication, Exparel, and rescinded a 2014 warning letter issued by the FDA's OPDP."


"In the past, when a company faced a letter it thought was erroneous, it complained to its lawyers and caved to the FDA. Now, following Pacira's example, such companies can ask for a meeting and probably get it. If not, they can seek court review."


"Expect more letters this year," said Kamp.

Pharma Guy's insight:

I say this is "Bull" because the trend is clearly fewer warning and untitled letters; http://sco.lt/6EoDk9 The number was so low last year, however, it is hard to believe that it could go lower! So, I guess, Kamp may be right after all!

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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 | Scoop.it

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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Review of Warning and Untitled Letters for 2014 - That Was Easy!

Review of Warning and Untitled Letters for 2014 - That Was Easy! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

As usual, risk minimization was the most frequent violation, followed by claims of superiority and unsubstantiated claims.

Pharma Guy's insight:


2014 Was Another Record Year for FDA: Fewest Number of Untitled/Warning Letters Ever!
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"One-Click Rule" Also Won't Work for Print Sales Aids Says FDA. Baaa!

"One-Click Rule" Also Won't Work for Print Sales Aids Says FDA. Baaa! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

According to a report by Alexander Gaffney in Regulatory Focus, FDA's Office of Prescription Drug Promotion (OPDP) issued an "unusual" warning letter to New Jersey-based Sciecure Pharma.

The letter took issue with the company's sales material promoting Doral (quazepam), a drug approved by FDA for the treatment of insomnia. 

The letter (find it here) cited several problems, including Omission of Risk Information, Unsubstantiated Superiority Claims, Omission of Material Facts, and Failure to Submit Under Form FDA-2253.

None of these is that "unusual" for problems cited in so-called "Notice of Violation" (NOV) letters. For example, 43% of such letters cite omission of risk information, and another 43% cite overstated efficacy, unsubstantiated superiority claims, and broaden indication (for more on that, read "Do TV DTC Ads Overstate Rx Drug Risks?").

Under "Unsubstantiated Superiority Claims" the FDA humorously refers to the "Image of a single white sheep among a group of four black sheep" on the sales aid cover (see image). More on the agency that designed this sales aid later.

It wasn't the sheep reference that made this letter "unusual" in Alex's eyes. So what did Alex find so unusual about the Doral letter?

Pharma Guy's insight:


Remember "The Girl from Google"? A classic!

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Joel Finkle's curator insight, November 25, 2014 3:39 PM

Entertaining article on Advertising regulations from FDA, and an attempted hijacking of online ad rules for print materials (it didn't fly).

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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 3:09 PM

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