FDA Bulks Up in 2008: part 3

Given the failure of Congress to appropriate adequate funds for drug safety, no one expects future FDA appropriations to add congressional money to the user fees that will be available for the database. That is why the agency hopes to also supplement user fees with funding provided by the Reagan-Udall Foundation, also being established by the FDAAA. The fund has a much broader purpose, however. It is a private foundation, modeled on the ones already used by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). The fund will raise its own operating budget. That money will be spent on collaborative research in which drug companies, academic centers, and others join together for research that would be dispersed broadly and whose results generally would not be patented. The kinds of research projects to be undertaken would be those on the FDA’s Critical Path Initiative (CPI) list.

The FDA established the CPI in March 2004. The CPI list includes 76 projects, but the FDA has funded only half a dozen or so. These projects cover biomarkers, animal models, inter-individual variability in drug response, data analysis technology and methodology in drug development, and improvements in designing and conducting clinical trials.

Some are concerned that because the Reagan-Udall Foundation will depend on private funding and because most (if not all) of that funding will come from the drug companies, it will serve the interest of drug companies, even though its 14-person board of directors will have representatives from widely diverse groups. Only four directors will be from the pharmaceutical, device, food, cosmetic, and biotechnology industries.
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Steve Walker, co-founder of Abigail Alliance, a patient advocacy group, says, “The Reagan-Udall Foundation is the only provision of the bill with real potential to improve the FDA, but there is a real chance it won’t accomplish that goal.”

He argues that the foundation has no authority to impose change on the FDA. It can fund only research, the results of which the FDA can choose to accept or reject.

“The FDA is a profoundly change-resistant agency and will likely reject or weaken any recommendations for real change from the institute,” he contends.

The Republican Senate staffer who worked on the FDAAA says that some of the concerns raised about the foundation are “misconstrued,” but she does acknowledge that the legislation allows drug companies to make “directed” donations based on bylaws to be developed by the board of directors; some of the research would be patent-able, again based on board policies.

Just as there are skeptics of the Rea-gan-Udall Foundation, however, some are more optimistic. Mary Richards, Deputy Chief Executive Officer of the Parkinson’s Action Network (PAN), says that the development of a bio-marker for Parkinson’s disease would be of “huge, huge importance” to the Parkinson’s community. It might not only hasten development of a drug that would be effective in the later stages of the disease—a drug that does not exist today—but might also allow for better diagnosis. buy kamagra

Although this is the type of research we expect the foundation to fund, two questions remain:

  • Can the foundation’s board of directors ensure that money will come in from multiple sources?
  • Will the money be applied on the basis of strategic public health needs?

Ms. Richards states: “I think there will be a lot of scrutiny around that.”

Patients with Parkinson’s disease and many other conditions are hopeful about another provision in the FDAAA that would require drug companies to post more complete information about a clinical trial in progress on the NIH database. Right now, that Web site has only limited information posted by the sponsor when the trial gets under way before the drug is approved. The FDAAA substantially increases that early information; mandates new search features for users; and, perhaps most importantly—and most controversially— forces companies to post, for the first time, the results of Stage II, III, and IV clinical trials after a drug is approved.

The post-approval information must also include links to FDA reviews of the clinical trials and to medical journal articles in which the trials are discussed. This must be accomplished within 90 days of the FDA’s approval. The bill allows the FDA to levy those $250,000 and $1 million civil penalties against recalcitrant companies. cialis professional online

The House bill had included a provision forcing companies to submit summaries of their clinical trials in “layman language.” PhRMA fought to have this provision kicked out of the bill be cause of concerns it would expose drug companies to liability for making promotional claims and because it felt clinical trial results were useful only for medical professionals.

Eventually, Congress eliminated the lay language provision. Instead, House and Senate members agreed to language requiring the FDA to finish making its rules in three years. They also debated whether to require a summary of the clinical trial and its results, written in nontechnical, understandable language for patients, “if the Secretary determines that such types of summary can be included without being misleading or promotional.”

Even patient activists have disagreed about whether it is good to add clinical trial results to the. According to Mary Richards of PAN, the detailed additional clinical trial data that will become available will allow Parkinson’s patients to make better decisions about new therapies. Many disease communities, including those involving Parkinson’s disease, are experiencing low participation rates in new trials. She explains:

By providing greater data transparency and access to results information, we believe that will enhance awareness and understanding of trials as well as secure greater trust in the clinical trial process. . . . Ultimately, adequate enrollment in trials is essential for bringing new drugs to the market, and this provision may have a positive impact on the current participation issues.

However, Steve Walker believes that tossing huge masses of data from clinical trials into the public domain will give the Steve Nissens of the world more fodder for creating fiascos. He says:

I asked Congress to go back to the drawing board on posting clinical trial data and figure out how to make it available in a manner that would effectively limit irresponsible snipers from doing statistical drive-by hits on the integrity of our drug approval system. Obviously, they didn’t do that, and I think that was a big mistake. kamagra soft tablets

The FDAAA will give the FDA more money and authority in 2008 and beyond, but it doesn’t do everything that many inside and outside of Congress had hoped for. The bill gives the CDER statutory authority to require REMS for the first time; however, in the past, the agency has demanded that drug companies produce Risk Minimization Action Plans (RiskMAPs) for some drugs for which questions about safety rivaled their benefits. Those RiskMAPs required the companies to provide medication guides for the drugs, for example, as REMS will do. Many in Congress wanted the FDA to require REMS for all drugs. The authority in the FDAAA pertains only to drugs for which REMS are needed to ensure that the drug’s benefits outweigh the risks.

Neither does the bill give the FDA new authority to restrict the advertising of new drugs, a power that many outside groups and many Democrats in Congress had favored. Of course, the passage of any significant new legislation is subject to all kinds of compromises. In the case of the FDAAA, the finished product clearly improves the FDA’s bargaining position with drug companies on matters of safety. In the end, having additional leverage is one thing; using it effectively is another.

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