FDA is raising major objections to the Office of Management and Budget's
proposed risk assessment standards, saying they could block FDA from
warning doctors and the public about side effects of marketed drugs and
would make it difficult to help the public during a pandemic flu. FDA is
under political pressure to let the public know earlier about potential
dangers of approved products, and OMB's draft guidelines would make it
nearly impossible to do so, says FDA drug center chief Steve Galson.

But a critic of FDA’s position says the data-quality law exempts agency
decisions during a public emergency such as deadly flu outbreak.

At issue is a “risk assessment bulletin” released by OMB in January that
aims to improve how federal agencies assess risk when developing
policies. The bulletin helps implement the Data Quality Act (DQA). The
National Academy of Sciences is peer reviewing the document, and Monday
(May 22) an NAS panel heard what various agencies had to say about it.

FDA will submit detailed comments later.

Representatives from FDA, the National Institutes of Health and the
Centers for Disease Control and Prevention all complained that the
bulletin is too broad to implement because of both timing and financial
constraints.

FDA reviewed 109 alerts it issued last year -- including public health
advisories, a drug information page, and doctor and patient information
sheets -- that yielded nearly 200 documents. Of those, 92 documents
would have been defined as risk assessments by the bulletin, which means
FDA could not have released them, and 28 were borderline.

Galson said it is difficult to determine if a product on the market is
to blame for adverse event reports FDA receives, but the agency may want
to let doctors and patients know about potential problems with a product
anyway. The public sends FDA thousands of e-mails a day asking about
adverse events.

“They don't want to wait for us to do that complex risk assessment,” he
said, adding that the real risk assessment is often made in the doctor’s
office based on information available to the doctor and patient.

“The public health interest may be to tell the public about an adverse
event before a dose-response relationship can be defined.”

Industry has said in the past that FDA's drug safety plans would violate
the Data Quality Act. FDA is proposing a “Drug Watch” Web site as a key
part of changing how the agency ensures the safety of drugs post-market.
Under the plan, a drug safety board made up of members from FDA and
other agencies is supposed to review emerging safety data and decide
what goes on the Drug Watch Web site. But Galson said in December that
FDA was going “back to the drawing board” on the Web site after
receiving a flood of negative comments from drug companies.

Some lawmakers, and patient and consumer advocates began pushing for
drug safety changes after a string of bad press on certain
antidepressants, which now carry a warning of increased suicidal
ideation in adolescents; Cox-2 inhibitors such as Vioxx, which was
pulled from the market over fears the drug causes heart attacks; and the
acne drug Accutane, which is strictly regulated using a registry.

Galson named these events as prime examples of public health advisories
FDA could not have made under the proposed bulletin.

“This is something FDA put out information on before the full risks were
known,” he said.

The bulletin also would hinder FDA in alerting the public to potential
communicable diseases, Galson said.

“A new communicable disease comes up and we have to put out some
information about a test that is used to diagnose it or a vaccine, it is
very difficult to put it in context,” he said. “It would be
inappropriate in fact to put it in context because sometimes there isn't
a comparison. The comparison is no treatment at all.”

Galson said other routine administrative procedures such as classifying
medical devices, also would be difficult if the agency were required to
first fully assess risk.

It is difficult to make rules for the entire government to follow,
Galson added. Those pushing the standards were in large part interested
in risk assessment standards used by the Environmental Protection
Agency, and those stakeholders have not contacted FDA, Galson said.

Bruce Levinson with the Center for Regulatory Effectiveness, which was
the primary force behind the DQA, said public emergencies are exempted
from the law so Galson's pandemic flu example does not apply. As for
telling the public about adverse events, FDA can make adverse event data
public, but it should not put its own spin on it without properly
assessing risk, he said. If FDA is worried about a product based on
adverse event reports, Levinson said the agency should have criteria for
determining when it meets that threshold.-- John Wilkerson