FDA Would No Longer Have to Negotiate Safety with Drug Manufacturers
Unfortunately it took more than a year for the US FDA and Merck & Co. to agree on labeling changes for the now recalled drug Vioxx after information about possible increased cardiovascular risks, namely heart attacks and ischemic strokes, first came to light in 2001. That was because, remarkably, at present the FDA must negotiate drug-safety labeling changes with the drug manufacturers. Moreover, the FDA technically cannot order a prescription drug off the market, i.e., demand a recall, without undergoing an administrative procedure which can take many months, even years.
In a move which seems long overdue, Senator Chuck Grassley (R., Iowa) and Senator Christopher Dodd (D., Conn.) are co-sponsoring a bill which would change this "hard-to-believe" situation. Their bipartisan bill, introduced yesterday in the Senate, would give FDA the power to order unsafe drugs off the market immediately. It also allows the FDA to order the pharmaceutical companies to make changes to their drug warning labels -- without the FDA having to go through the often lengthy process of negotiating those changes with these companies, while the subject drug is still being dispensed (and used) with the deficient warning language in the so-called "package insert".
In addition, the Grassley-Dodd bill would move the FDA's drug-safety office out of the agency's branch which is responsible, initially, for evaluating and deciding whether to allow new prescription drugs to be sold for use by patients in the United States. This proposed legislation would create a new center for post-market review of approved drugs, and put the drug-safety office over there, giving this FDA department increased independence. Furthermore, the legislation would allow the FDA to mandate that drug companies conduct post-marketing studies on the safety of their prescription drugs. It may come as a shock to many to know that, today, the FDA does not have the power to order these companies to conduct studies concerning the types and frequency of serious side effects associated with their prescription drugs. And because the drug company doesn't have to do these side-effects studies, they are not done for the most part.
Coincidentally, Novartis AG is currently engaged in a battle with the FDA over the agency's effort to have this drug manufacturer relabel a prescription eczema cream, Elidel, which studies have linked to a possible cancer risk.
One hopes that the Grassley-Dodd bill is the beginning of a much needed effort to establish the FDA as a protector of patients instead of foot-servant to the drug companies. Notably, there is a similar bill proposed in the House by Rep. Maurice Hinchey (D., N.Y.).
We will keep you posted on the status of this bill; and, when the time comes, you should urge your representatives in Washington to support this legislation.
(Posted by: Tom Lamb)