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Activist Meeting With FDA Drugs Division Sets Broad Agenda for Change

Counting Our Blessings

The night before the FDA meeting on 14 November 2003, twenty-five of your favorite activists at-large were putting together the game plan of how to engage with the FDA, on exactly what points. In typical AIDS activism fashion, within half an hour of starting the discussion, even though we had an agenda, we were talking about everything from ADAP subsidies to what is done and how they do it in Europe. Chaos sets in easily and once established, is hard to dispel and get back on track. Someone finally asked about how something was done 14 years ago, and that was the break needed to get Mark Harrington up to the white board that extended throughout all four walls almost floor to ceiling (the activists’ version of a padded cell?). Rob Camp reports.

Mark took the opportunity to go year by year through the history of treatment activism, and by the time he had covered the second wall with notes and dates, we had the outlines of a plan. It was his recounting of the storming of the NIH that made us see that it was perfectly sensible that he would review for the FDA the next day what we (community + authorities) had historically accomplished, and where we would like to go from here. Although some of the FDA team had been around from the beginning or the near-beginning, there were many new people (there were more FDA people coming than activists — some 35 vs. 25!) who could do with a recap, including some from the community — on issues as basic as the importance of Commissioner David Kessler, and the introduction of accelerated approval. Because readers of TAGline have been following the last ten years of AIDS through our monthly series, I’ll spare you the details; but once again, in a very engaging and succinct way, Mark brought us all into the realm of not forgetting history in order to figure out where we need to go.

After his recount (à la Guernica), we tried to focus on what we wanted from the FDA in the upcoming months and years, remembering that the FDA is concerned with “accuracy and safety” vs. any risk/benefit ratio looked for by, say, the EMEA, its European counterpart. The FDA had agreed to this meeting, so in some ways probably realized that it may be time for some tweaking of the rules.

The agenda of the FDA meeting itself had been refined over the previous months, and we only had half a day to pack into it a lot of desires, hopes, frustrations, needs, etc. Mark started off the day according to what we had discussed the night before, and finished with a list of where we want to be. Some of the main points are issues that we have been bringing up in the TAG/community position papers over the last year, including:

  • More data on pharmacokinetics of drugs in more diverse populations.
  • More drug-drug interaction studies completed at the time of approval, including studies with methadone, birth control hormones, and TB drugs such as rifampin, and of course with the most commonly used protease inhibitors and NNRTIs.
  • Study populations need to reflect the makeup of the epidemic by adequately representing women and people of color. New relationships need to be fomented with clinics capable of enrolling more diverse groups of individuals.
  • After drugs have been approved, promises made by companies to continue post-marketing research should not be allowed to languish. Currently the agency has no effective way to compel completion of these Phase IV “good-faith” commitments, and pressure on Congress to give the FDA more leverage may be needed.
  • Better systems must be implemented to monitor chronic and/or long-term side effects after drugs are approved. The current adverse events reporting system is voluntary and may miss early signals of toxicity. A network of “sentinel practices” that would report unusual symptoms might be a viable enhancement to our early detection system. The need for a better system to detect and track side effects such as lipodystrophy syndrome after drugs are approved is a top concern for the community.

These “themes,” in one way or another, reflect the questions that we come home with after approval of every drug, and that we don’t ever seem to get the answers to: Is the drug effective? What are its benefits? What are its risks? How should the drug be used? Who will benefit? And, what is still unknown?

The FDA Directress of the division of antivirals then spoke, on what she saw as the value of the two of us working together, and mentioned the importance of the position papers the FDA had been receiving from us over the years. She suggested that we get the papers in a little earlier, in order to help them define their priorities, and so all their salient points can be better addressed either at the public hearing or at the time of the announcement. (They actually “close” their review approximately one month before the announcement.)

Cohort studies is another area that the FDA feels it needs to get involved in, and following the large simple trial idea of many years ago (that was never really taken up), could be an effective way of not only seeing long-term results, but achieving an efficient clinical monitoring over a long period of time. With so many me-too and near me-too drugs coming up, should the bar be raised for them? Do we want to see less side effects, better resistance, efficacy in otherwise unresponsive patients? Of course, if a drug does have one of these attributes, is it truly a me-too?

The FDA Commissioner then came up to the podium to offer his view of where he saw the FDA heading — in terms of the politicization of the agency, drug reimportation, and a more effective side effects monitoring system (based on a National Cancer Institute model).

His speech seemed to be hitting all the right political buttons with us, making us all warm and fuzzy, showing that he is a very good politician, but also raising the concern that, in fact, he is a very good politician (and nothing will be made better).

We asked him about the “religious crazies” and other ideologically driven anti-regulatory types who may want to change the FDA agenda or even dismantle it completely, and their effects within the FDA. The Commissioner categorically denied that any of that is going on within the FDA, and left me with the feeling that they must be a city on some other hill forgotten by the likes of Karl Rove and William F. Buckley.

Also, the FDA is perceived to be responsive to industry instead of to the consumer, and maybe that perception should be the other way around. The FDA is also often scapegoated as the guilty party in asking too much from pharma, which is presumably why there is so little moving through the system. We offered our alliance to the FDA in demonstrating however we can that that is not the case (they do not ask too much from industry, pshaw!), and vigilance must be maintained. The community can lobby Congress on expanding the FDA’s budget in order to continue doing such a valuable, rigorous work as well as expand their mandate over Phase IV surveillance etc.

Questions were brought up re: the need for more exhaustive monitoring and design of drugs regarding hepatic issues. Also, we expressed desire to have more input in the package insert.

The four HIV drugs that were approved this year were then each briefly presented by the head of the evaluation team for each drug. They knew their stuff, and all except the atazanavir presenter were willing to share doubts and concerns with us, and were interested in hearing our preoccupations. They all seemed serious, rigorous and sincere in the belief that they had done a complete review of all of the drug data before approval. The community can only count their blessings that we have such a smart and dedicated group of people who do this for our protection. One outstanding bit of data announced is that 11% of T-20 patients need narcotics to control the painful injection site reactions.

Maybe I did not say loud enough at the meeting that I find the public hearing aspect of the whole process one of the most transparent and heartening educational activities done anywhere in the world, and would like them to do that for as many drugs as possible — even the most unexciting me-too around.

Some unresolved issues (on our part as much as on the part of the FDA) are access to expanded access programs, oftentimes limited to white gay men, in a not-only white gay men disease. Advertising and promotion is a big piece of meat that we couldn’t fit onto the agenda this time. A few perfunctory developing world issues came up, which can be found in the ATAC minutes on our web site (

The CDER division (drugs) of the FDA were the presenters that day, and the other division, CBER (biologics, “blood”) expressed hope to meet with us in the not too distant future re: trials and candidates for an AIDS vaccine. Although the acting deputy director of CBER said a few words, she emphasized that a full meeting with us is needed for consultation. We are honored to be so highly considered.

I want to express thanks to community members who did an outstanding job at this meeting and in its preparation, including Mark Harrington, Lynda Dee, Bob Huff and Daniel Raymond. For a more detailed account of what happened, please see the excellent article in November’s GMHC Treatment Issues by Bob Huff, “Treatment Activists Meet With the FDA,” which I have freely used as reference for this article. Also, the minutes mentioned above were developed by Cathy Olufs (Los Angeles) and Fred Schaich (Portland) that helped fill in this article.

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