Will the FDA be Steadfast in Showdown with Big Pharma Over Drug Watch Plan?

The FDA intends to post emerging drug-safety concerns that are being evaluated by the agency on a new "Drug Watch" web site. The FDA proposed the Drug Watch web site in the wake of the Vioxx debacle, which included allegations that FDA officials suppressed drug-safety warnings by the agency’s staff scientists about that now-recalled arthritis drug. On the FDA’s primary web site, the agency says that the purpose of creating this new Drug Watch site is to make sure patients "have quick access to the most up-to-date and emerging product information" for making treatment decisions.  Consistent with that purpose, FDA officials promised to release emerging drug-safety information sooner, including posting it on the Drug Watch site.

To most of us, this Drug Watch web site sounds like a step in the right direction for the FDA.  But then there is Big Pharma….

The large drug companies oppose the Drug Watch plan because they imagine that there will be unnecessary confusion and "irrational fears" about their respective drugs if patients are given access to early information about potential drug side effects.

In early August 2005, the Pharmaceutical Research and Manufacturers of America ("PhRMA") said in written comments to the FDA that the type of emerging drug-safety information which the FDA might post on the Drug Watch web site "is too vague and preliminary to be of any value in making informed treatment and prescribing decisions."  The PhRMA comments about the Drug Watch plan went on to state:  "Such information is … not likely to accomplish anything other than confusion among physicians and the public and creation of irrational fears about the safety of drugs on the list."

When asked about the drug companies’ opposition to the Drug Watch plan, PhRMA President Billy Tauzin was quoted by Reuters in August 2005 as complaining:

There’s a deep concern that bad information gets into the system … and people stop using drugs they need.  [However,] I’d rather have them (FDA) doing it than some blogger.

Seemingly on that same level of logic, PhRMA argued in their written comments to the FDA that releasing emerging drug-information on the Drug Watch site may violate a law requiring data released by federal agencies to be useful. PhRMA also asserted that the Drug Watch plan may exceed the FDA’s authority.

Let’s hope that the FDA will be steadfast in this apparent showdown with Big Pharma over the agency’s Drug Watch plan.

(Posted by: Tom Lamb)