is a continuation of the first post, Things
That Affect YOU: PDUFA and AERS. PDUFA is
Drug User Fee Act. AERS is the Adverse
Event Reporting System.
The PDUFA is up for review soon, as it expires in September.
If it expires, 40% of the funding for premarketing drug
This has been covered only minimally by the mainstream media.
There is an article on Bloomberg.com (FDA
`Addiction’ to User Fees Comes Under Attack: Cindy Skrzycki),
and on the Washington Post (FDA’s
User-Fee Habit). Actually, both of these links take
you to the same article, but it was published in two different places.
Perhaps in recognition of the scant attention being paid to this issue,
the New England Journal of Medicine has published three editorials on
the subject. My previous post covered the first; this post
the second: Drug
Safety Reform at the FDA — Pendulum Swing or Systematic
Improvement? Mark McClellan, M.D., Ph.D.
McClellan is a former FDA Commissioner, and is currently a fellow at
Joint Center for Regulatory Studies. From their
response to growing concerns about understanding the
impact of regulation on consumers, business, and government, the
American Enterprise Institute and the Brookings Institution established
the AEI-Brookings Joint Center for Regulatory Studies. The primary
purpose of the Joint Center is to hold lawmakers and regulators
accountable for their decisions by providing thoughtful, objective
analyses of existing regulatory programs and new regulatory proposals.
So they are basically an laissez-faire, libertarian kind of institute.
Even so, Dr. McClellan is not entirely opposed to regulation
the imposition of greater costs on the industry. He points
out that the Institute of Medicine recently concluded a report (Assessment of
the U. S. Drug Safety System) on recommended changes to the
FDA. He places the recommendations into four categories:
first is increasing the resources for drug-safety activities. The IOM
noted that the FDA and its Center for Drug Evaluation and Research
(CDER) are “severely underfunded” and recommended significantly
increasing Congressional appropriations…
second category of proposed reform is new authority for the FDA. A bill
sponsored by Senators Edward Kennedy (D-MA) and Mike Enzi (R-WY) would
formally authorize the agency to use a range of regulatory tools to
help assure drug safety. The new authority includes the ability to
require special medication guides for patients, restrict which
physicians can prescribe a drug, and impose special requirements for
prescribers (e.g., documentation of laboratory testing through
FDA-approved monitoring procedures)…
third aspect of reform could help avoid increased costs and reduced
access from new drug-by-drug regulation: implementing a fundamentally
better system for postmarketing surveillance, with the development of
better risk information based on actual experience with every new
the IOM report recommended changes in FDA management practices and
safety oversight. The FDA says it is implementing many of these,
including new dispute-resolution processes and increased participation
of drug-safety and epidemiology experts throughout the review
other words: more money, more regulatory authority, better
postmarketing surveillance, and better internal management.
Dr. McClellan points out some pros and cons to each. He
agrees that more money is needed, and thinks that it should come from
both increased industry fees, and increased
congressional appropriations. He is ambivalent about the
recommendations for increased regulatory authority, arguing that there
could be “deleterious effects on access to treatments.” He
agrees that improved postmarketing surveillance is needed.
The current AERS is entirely voluntary,
and it is thought to greatly under-report the incidence of adverse drug
reactions. He is ambivalent about the prospect of
Regarding the proposals to increase regulatory authority and to make
changes in internal management of the FDA, he states these “may help.”
Personally, I think all four recommendations should be implemented.
Right now, the FDA has no authority to compel manufacturers
to complete postmarketing safety studies. It also has no way
to reward companies that comply with these recommendations.
Regarding organization changes, I would say this: if we are
going to keep the current structure of user fees, there has to be some
way to counterbalance industry influence. That could be done
by having an administratively separate division, with separate funding,
that oversees the pre- and post-marketing safety evaluations.
Basically, what I propose is this: Since drugs have to be shown to be
safe and effective, we could have one branch funded by user fees that
evaluates effectiveness. Another branch, funded by the
public, would evaluate safety.