The Guidance that Dare Not Speak Its Name

In December 2014, Commissioner Hamburg announced a proposed change in the FDA’s long-standing policy regarding blood donations from gay men – See “FDA Commissioner Margaret A. Hamburg’s statement on FDA’s Blood Donor Deferral Policy for Men Who Have Sex With Men“. The term “men who have sex with men” was coined as a means to be inclusive of those men who have sex with other men who do not identify themselves as being gay – perhaps with good intentions so that the message reach the target audience.

For many years – since 1985, the policy on the subject of blood donation was draconian, deferring donations from any men who have had sex with men since the year 1977 – even if the sexual episode occurred only once – despite the increasing ability over time to screen and detect the presence of a virus. This was a policy opposed by many groups for many reasons – from the medicine and science and from a human rights point of view. The American Medical Association had stated that it supported scientifically based blood donation deferral and opposed the lifetime ban.

This week, FDA issued a draft guidance awaited since the December 2014 statement by Dr. Hamburg “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” which is, let’s face it, about blood donation by gay men, though you might not get that from the title. There was no press release and there was no blog posting on FDA’s Voices blog, but the revised recommendations are a significant departure from the old ones. Under the new recommendation, blood donations will be deferred from a specific list of characteristics that include men who have had sex with men within a period of one year.

The change is well past time. When the AIDS epidemic first emerged, individuals and institutions – both public and private – often took extreme measures in response and these extreme responses were often not based on science, but on unfounded concerns or fears. And too often these extreme responses were formalized into policies – policies that had the opposite impact of what was intended. Rather then act to protect, they harmed. People with HIV were not allowed to travel or immigrate to the United States. Needle exchanges which could save lives were not funded. Correcting these mistakes took decades.

As bad policies go, the lifelong ban on gay blood donation may not be the worst – it was a waste of a potential resource. But it did represent a policy not premised on science but on fear – and further stigmatized gay men. That may seem to some unimportant, but be clear on this – stigma kills. Especially in the dark early days of the epidemic, children thought to have HIV were kicked out of schools, people lost their jobs, patients were denied services. Stigma has a real cost to those who feel the brunt of it.

And in the case of FDA, stigma can backfire. The development of policies based not on fact, but on the weak premise of theoretical conjecture not only wastes valuable resources and contributed to the stigma of a group of people, it erodes the credibility of the policy maker. And for an institution that is charged with protecting the public health – credibility is a commodity that cannot be squandered.

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Weekly Roundup 5.8.15

It is one of my three favorite times of year – the days are so much longer – the evenings cool and pleasant for sleeping near open windows – the mornings crisp and the afternoons languidly warm. Flowers abound. There is a lot of birdsong. It is a good time to be living in the moment and not worrying about the future or the past.

Though speaking of the past, we will cast our eyes backward just a bit to see what the week brought us of interest. And then look onward to the weekend and next week, when I promise an interesting posting about Advisory Committees.

In fact, the folks at FDA must be enjoying Spring too. There were no press releases from this agency, which normally has a lot to say, but which can suddenly from time to time go all quiet. But other than press releases, there were some items of note:

  • FDA Withdraws 47 Draft Guidance Documents – As the entire community of people who waited for 5 years for FDA to come forward with draft guidance documents related to the social media and internet will attest, the agency is not very speedy when it comes to drafting, developing and issuing these important documents. And once the draft guidance documents come out, and the agency collects input through open dockets, a final version may take months, years, and even more than a decade to come into being. This week the agency decided apparently to clean house by announcing the withdrawal of 47 draft guidances that were developed before December 31, 2013 and never finalized. The complete list can be found here, and includes some documents going back to 1991, during the first Bush presidency. It is good to remove the clutter, but even better to improve the process.
  • Senate HELP Committee Questions FDA on Biosimilars – And speaking of guidance, Republicans on the Senate HELP Committee has sent Acting FDA Commissioner Stephen Ostroff a letter to express concern over FDA’s implementation of regulatory pathway for biosimilars. Specifically, they noted that the agency has not provided guidance on a number of fundamental issues, even as biosimilars are coming before AdComms for consideration for approval. The letter stated that the agency has not provided guidance on issues relating to the review and approval of applications for biosimilar products such as naming, interchangeability and production of patent information. They also expressed concern that guidance remains in draft form at this stage and set forth a list of questions that sough answers from the agency by May 22.
  • AdComm Set to Consider NDA for HSDD Treatment – A joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee with the Drug Safety and Risk Management Advisory Committee has been set for June 4 to consider an investigational treatment for hypoactive sexual desire disorder (HSDD). This is significant on a number of fronts. First and foremost, while there are many treatments available for male sexual disorder – erectile dysfunction, there are no approved treatments available for women. Secondly, the meeting comes after a 2-day Public Workshop on the subject held by FDA in the Fall of 2014 – the materials from which can be found here. And third, many therapies have been explored, none have been approved. This is one to watch.

That’s all from me this week folks. Have a wonderful weekend. And next week, look forward to some observations on AdComms.

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Weekly Roundup 5.1.15

Happy May Day!

As much of the world celebrates the worker, here we toil to bring you this week’s latest. We are well into the second quarter of the year – hard to believe – and are having those kinds of days that require we dress in layers. The kind of day where you can go out and see people still wearing heavy coats and stocking caps walking next to the person wearing shorts, t-shirt and flip-flops. There is weather for everyone.

And here are a few things for you.

  • FDA Announces Proposed Rule on OTC Antiseptics – The agency announced this week that it was issuing a proposed rule that would amend the 1994 tentative final monograph for OTC antiseptic products. The agency is focused on the use of such antiseptics by health care professionals, particularly in a hospital setting, where there is frequent exposure due to heavy use. While the 1994 monograph proposed certain active ingredients as “generally recognized as safe” (GRAS), the agency is now looking for additional safety data to support the use of such ingredients as well as some additional safety data that will include in vitro data that characterizes the antimicrobial properties of the ingredients along with in vivo clinical simulation studies. The proposed rule is open for public comment for 180 days (due October 28, 2015) and the docket can be found here.
  • Generic Abilify Approved, OPDP Letter on Brand AblifyFDA announced that it was approving a generic version of Abilify (aripiprazole), an atypical antipsychotic drug approved for use in treating bipolar disorder and schizophrenia in multiple strength and dosage forms. Coincidentally, the agency’s Office of Prescription Drug Promotion (OPDP) also posted its fourth regulatory action letter of the year – an untitled letter – addressed to the brand name manufacturer of Abilify.

That’s it for me this week. Have a good weekend and for those of you who are celebrating the holiday today, enjoy.

CORRECTION -5.2.15 – A reader wrote in to point out that the FDA draft guidance on biosimilars was issued in February 2012, not February of this year and that was indeed correct. Apologies for the error. The text has been corrected above.

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FDA Press Releases – 1st Quarter 2015

Last year I began a new database that tracks the press releases of FDA as a way to see what news the agency is talking about and provided a year end look at 2014. Looking back at the quantity and subject matter can lend some perspective into trends that may be developing. Unlike OPDP Warning/Untitled letters, with press releases there is some volume.

And what we can plainly see is that this quarter, FDA has had much more to say this quarter than the same quarter a year ago with 45 releases so far in 2015 compared to 34 in 2014. What is all the news about? Approvals, approvals, approvals.

Here is at what FDA had to say during the first quarter of 2015, with a comparison to the year before:

Among the nearly twice as many approvals announced in the first quarter of 2015, there were 11 devices, 18 drug and 1 app, which compares to 5 device and 11 drug during the same period last year. In his maiden speech given before the Food and Drug Law Institute, acting FDA Commissioner Stephen Ostroff noted that last year, the agency approved 51 new molecular entities. If they keep pace with this quarter, 2015 would certainly likely surpass that number.

We’ll have to see what happens in the second quarter and we’ll look again.

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Weekly Roundup 4.24.15

It is that time of year when the temperatures can range by 30 degrees from morning until afternoon. The pollen counts are high and already sudden storms appear on the horizon to dump a lot of rain and then move on as if nothing had happened. One marvels that the year is already one-quarter passed. Vacation plans are made for summer. Blooms are blossoming in rapidly growing numbers. Bugs are not yet out. Every so often, it is a good time to stop, look around and realize that life is good.
And here is a bit of what happened this week:

  • FDA and Device Data from Outside the U.S. – Foreign clinical trials can be less expensive than those in the U.S. but circumstances around the conduct of those trials can vary. This week FDA announced a draft guidance related to devices called “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the U.S. and has opened a docket that is scheduled to close on July 20, 2015. The agency said that the guidance describes the special considerations when using data from outside the U.S. and while the draft does not describe new policy, but describes FDA’s existing approach to this issue.
  • FDA Warns on BMPEA – This week the agency sent five Warning Letters (non-OPDP) to companies regarding products labeled as dietary supplements which contained the substance Beta-methylphenethylamine – also known as BMPEA. As the letter states, a dietary ingredient is a vitamin, mineral, herb or other botanical and BMPEA is not and therefore products containing it are misbranded if labeled as a dietary supplement. In addition, it was noted that BMPEA is not an approved food additive, nor is it included in substances with GRAS (generally recognized as safe) status. The list of warning letters can be found here and a specific example of one of the letters here. The sending of multiple letters by the agency could reasonably be interpreted as enunciating or illuminating a policy position.
  • Acting FDA Chief Speaks – Just 14 days into his new role as the Acting Commissioner for FDA, taking the place of former Commissioner Margaret Hamburg, Dr. Stephen Ostroff spoke at the annual meeting of the Food and Drug Law Institute. He acknowledged the role of the former Commissioner in leaving the agency in a stronger position than when she assumed her office. His remarks were entirely¬†focused on the accomplishments of the past year – the approval of 51 new molecular entities last year, including more orphan drugs than at any other time and 17 of which were “first in class”, and two-thirds of which were approved in the U.S. before anywhere else and noting that a large number of them occurred under one of the agency’s expedited programs for new therapies; citing the role of FDA in assisting families seeking access to promising investigational drugs; bolstering the role of women and minorities in clinical trials, and several other achievements.

That’s it for me this week. Have a pleasant weekend. Enjoy.

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