Warning and NOV Letters Plummet in 2014

There are two types of letters issued by FDA’s Office of Prescription Drug Promotion (OPDP) related to its role in regulating the commercial speech of medical product manufacturers – Warning Letters (WLs) and Notice of Violation (NOV) letters. One can see here that in 1998, the OPDP’s predecessor – the Division of Drug, Marketing, and Advertising Communications (DDMAC) issued a total of 156 letters.  However, beginning in 2000, the number of letters issued began to drop precipitously to just 75.  By 2002, the office was generating less than 30 a year – with a slight increase experienced 2009-2011. However, 2014 is a banner year – producing the least number of letters by far – 10. Depending on your point of view you could say that OPDP has either stopped looking for violations or industry has gotten really proficient at communicating within regulatory parameters.

But is it as simple as all that?  There are two primary means by which FDA enunciates policy.  One is through the laborious and lengthy process of Guidance production. Guidances are drafted and published as drafts – a docket gets opened and the public has opportunity to comment.  The development of a guidance may take place after a public meeting on the topic to allow input.  All of this takes a great deal of time.  The other means by which FDA lets those outside know what it is thinking is through the issuance of Warning and NOV letters which clarify policy and sets parameters – or guideposts – for the guidance documents.  When you don’t have much in the way of guidance, and you don’t have much in the way of letters, you don’t have much insight into FDA’s thinking.

For example, let’s consider the guidance development process for social media.  The agency first held a public meeting in November 2009 and opened a docket for written commentary. Preliminary estimation was that draft guidance would emerge by the end of 2010.  Many expected an individual guidance that covered all of the various aspects of social media. But that did not happen and it was not until 2011 that a guidance even mentioned a very particular aspect of social media and not until 2014 that some substantive guidance was finally delivered – and even with that, there are still many open questions.  FDA opened a docket to get input into the social media guidances from 2014 and even extended the comment period until late in the year – all in all – five years.

But during all of that time, very little insight was provided through the production of letters that would shed light on the agency’s take on social media – and their enforcement of these guidances.  In fact since 2009, there have been only a handful of enforcement actions relating to a social media function – two having to do with Facebook.  In addition, there was one letter related to a banner advertisement.

In spite of this, there has been a true ascendance of the use of social media by patients, patient organizations, pharmaceutical, biotech and device manufacturers, healthcare reporters, and even FDA itself, though not OPDP.

In years past, Eye on FDA has provided a quarterly summary of the Warning and NOV letters, but this year with so few, there was no point in doing it quarterly.  An overview of all 10 letters will be the subject of an upcoming Warning Letter Summary for 2014. However we are giving it a few more days to ensure that FDA does not post any further letters for 2014.

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Biggest 2014 FDA Stories

Of course, it is entirely a subjective matter to pick out the most interesting stories of the year. When it comes to an agency that oversees the regulation of one-quarter of the U.S. economy spanning everything from medicines to cosmetics to (some) food to packaging. In other words, it all kind of depends on where you have your hand on the elephant. Nevertheless, I’m taking a shot here at naming what I think were the biggest developments out of FDA this year.  I did not focus on therapeutic breakthroughs, though there were some real advances in Hepatitis C, oncology and prosthetics, but more on stories that give us insights into the agency and policy.

Here goes:

  • FDA Changes Stance on Blood Donations from Gay Men – More on this front in a future posting, but FDA announced in December that it was changing the policy on blood donation from men who have sex with men.  It is an interesting story even if you are not in the blood industry or gay for many reasons, among them it provides a window into just how slow and laborious the process is when it comes to change at the agency. Prior policy had been that all blood donations from men who have had sex with men at any time since 1977 were entirely deferred. In December, FDA announced that it will be taking steps to recommend a change that will allow blood donation from gay men under the condition that it has been at least one year since any sexual contact (with other men). While a policy likely not to please anyone, it nevertheless is policy change from the long-standing prior policy. FDA will issue a draft guidance that will include opportunity for public comment. In the meantime, the agency has set up a Q&A page.
  • FDA Cold Storage Harbored Pathogens - At the beginning of July it was reported by CDC that the FDA cold storage area located on the NIH campus apparently held some old vials of various biological agents that included packaged vials of dengue, influenza, Q fever and rickettsia as well as smallpox.  At the time, the thinking was that this collection was assembled between 1946 and 1964.  FDA stated in an update in mid-July that the overlooked samples was clearly unacceptable and that the agency would be in the process of reviewing its policies and procedures and put into place a corrective action plan.
  • FDA Finally Has Something to Say on Social Media – Finally, I think the biggest FDA story of the year.  Health care is one of the primary uses for the Internet and the ascendancy of social media has not only provided powerful new platforms for communication, but has fueled a change in the way journalism is practices, including healthcare journalism. (Check out my piece on “Wall-Free Journalism“). After initially believing that existing rules on promotional speech by pharmaceutical companies covered social media in 2009, by year end, the agency changed its mind and held a public meeting to explore the unique questions posed by the rapid uptake in use of social media platforms, even as many companies began developing a fleet of social media assets.  The agency posed five questions at that 2009 meeting and while many expected a single guidance to answer them by the end of 2010, in fact it was not until this year that FDA answered at least some (though not all) of the topics discussed by issuing some guidances.  While in 2011 the agency mentioned social media in the context of a guidance “Responding to Unsolicited Requests About Off-Label Information” leading many to mistakenly consider this THE guidance on social media, and in 2013 produced some guidance on mobile medical apps, it was not until 2014 that there was some more expansive direction from the agency in the form of draft guidances affecting social media.  In January, FDA published “Fulfilling Regulatory Requirements for Post-marketing Submissions” and in June published two more – one on “Platforms with Character Space Limitations” and one on “Correcting Independent Third Party Misinformation About Prescription Drugs and Medical Devices“. (You can find links to all of these on the Eye on FDA Tab on Social Media. Unfortunately, in sum, as I said at the time in the Wall Street Journal Pharmalot blog – after the long wait, the result may be not much change.

Let’s get 2015 started.  Please accept my wishes for a Happy New Year to everyone.  May it bring good things and thanks again for being a reader of Eye on FDA in this, what will be the 9th year!

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Weekly Roundup 12.19.14

The holidays have left little time for posting, but here is at least getting in the Weekly Roundup. Hopefully, however, with the respite that is to come, there will be time to build up some editorial content.  In the meantime, between eating too many cookies and consuming too rich of holiday fare, there has been a burst of activity from FDA – perhaps as everyone gets ready to head out for the holiday.

  • Agency Approves First Pathogen Reduction System to Treat Plasma – Blood products can carry a degree of risk to transmit pathogens to the recipient that can be serious and even life-threatening, including HIV, hepatitis and West Nile Virus, among others.  This week FDA announced approval of Cerus Corporation’s Intercept Blood System which was found to be effective in reducing a broad range of viral and bacterial pathogens.  It works by utilizing a photochemical process that involves a controlled exposure to ultraviolet light and amotosalen, a chemical that facilitates the inactivation process and the plasma is then purified to remove the chemical and any byproducts.  You can learn more in the company’s press release.
  • FDA Announces Pharmacy Compounding AdComm – The subject of pharmacy compounding has been an active one over the past two years that culminated in the passage of legislation giving FDA new regulatory authority.  To that end, one of the newest development is the appointment of an advisory committee on compounding, the members of which were announced by FDA this week. The complete roster is available with links to their CVs.  A timeline has been assembled of compounding developments on a tab on the Eye on FDA site.
  • CHD Predictor ClearedThe agency announced this week that it had cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events for use in all adults with no history of heart disease.  Almost two-thirds of women and half of men who die suddenly from CHD have no previous symptoms. The PLAC test for Lp-PLA measures the activity of a biological marker for vascular inflammation – lipoprotein-associated phospholipase A2 (Lp-PLA2) – which is a condition associated with the buildup of plaque in the arties that supply blood to the heart resulting in a narrowing of the arteries.

Once again reminding folks that President Obama has made the 26th a holiday for federal employees and so for those watching for PDUFA decisions on or around that date, please take note.  That’s it for me this week – off to finally get those presents bought, wrapped and sent!  Have a wonderful weekend.

Photo of new baby Holsteins Courtesy of Anne Becker

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Weekly Roundup 12.12.14

Christmas cards not addressed because they aren’t bought.  Gifts aren’t wrapped because of the same reason.  I am definitely naughty.

  • FDA Expands Approval of Lilly’s Cyramza - The most common type of lung cancer, non-small cell lung cancer (NSCLC) saw a new treatment approved for use to treat it today when FDA announced it was expanding the approval of Cyramza.  The drug will be used in patients where the tumor has grown during or following treatment with platinum based chemotherapy, and will be used in combination with another chemotherapy – docetaxel. Cyramza was approved in April for advanced stomach h cancer adenocarcinoma and had an expanded approval in November to treat patients with advanced gastric adenocarcinoma, along with paclitaxel.
  • Garidsil 9 Approved To Prevent Cancer Caused by 5 Additional HPV Types – The agency announced this week that it was approving Gardisil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.  The agency said that Gardasil 9 adds protection against five additional HPV types—31, 33, 45, 52 and 58— which cause approximately 20 percent of cervical cancers and are not covered by previously FDA-approved HPV vaccines.
  • 2014 FDA Drug Approval Track Record – This week, FDA Commissioner Margaret Hamburg wrote on the FDA Voice blog an update on approvals of new drugs for 2014 and there were definitely some interesting notes.  She stated that even with a few weeks left to go (and there are some PDUFA dates out there), that the agency has in 2014 approved 35 novel new drugs, compared to 27 in 2013.  On top of that, something that has been highly noticeable this year is that many new approvals have been for orphan drugs and have been utilizing FDA’s pathways for enhanced approvals.  In fact, this year there were 15 approvals in 2014 or drugs for rare diseases, breaking the previous record from 2012 when 13 such drugs were approved. Finally, 15 of the drugs approved this year have been first-in-class compounds.  And we still have two weeks to go – though anyone with a PDUFA date that falls on December 26 should take note that President Obama declared that day a holiday for federal workers, so you may see your approval file in a little earlier.

That’s it for this naughty boy.  Have a good weekend and I hope you get your shopping done!

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Weekly Roundup 12.5.14

Time has been in short supply, but having survived Thanksgiving – guests, cooking and eating and gearing up for the gearing down of the calendar year (and the beginning of longer days) and it is time for a little breather. It is that time of year when we all stop and think about the year that has just gone by, and the one that is about to come. And while doing so, noting a little bit of what happened this week out of FDA:

  • First Drug Approved to Treat PolycythemiaFDA approved a new indication and use for Jakafi (ruxolitinib) for treating patients with a rare condition known as polycythemia vera – a chronic type of bone marrow disease that occurs when too many red blood cells are made in the bone marrow.  This can lead to swelling of the spleen, bleeding problems and clots in veins and can put patients at increased risk of stroke or heart attack.  The drug was evaluated under priority review which provides an expedited review of the application by the agency.  And because it is a rare disease, the drug also received orphan product designation.  Jakafi was approved in 2011 for other indications.
  • New Approval to Treat Rare Leukemia – While Jakafi was approved to treat a condition where the none marrow makes too many red cells, FDA also approved Blyncyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lympoglastic leukemia (B-Cell ALL), which is a rapidly growing type of cancer in which the bone marrow makes too many immature white blood cells. The drug is a type of immunotherapy and is the first approved drug that uses T-cells to destroy leukemia cells and is intended for patients who did not respond to previous treatment. This also had priority review and orphan product status and was approved under FDA’s accelerated approval program.
  • Final Rule on Pregnancy and Lactation Labeling Information - The agency announced that it was publishing a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in a prescription drug/biologic product label. The new content and formatting requirements will provide a more consistent way to include relevant information on risk and benefit.  The final rule can be found here and an FDA blog posting on the topic here and a draft guidance here.

That’s it for me this week.  Have a wonderful weekend everyone.

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