But one of the largest manufacturers of methadone said the FDA hasn�t talked to them.
�Roxane Laboratories has not been contacted by the FDA regarding any possible labeling changes for methadone tablets,� said spokeswoman Dawn Plante.
Another large maker of methadone, Tyco/Mallinckrodt, when asked for details about what changes might be made, referred a reporter to the FDA.
Patients are on their own
Even if the FDA decided to change the label on methadone tomorrow, the agency could not do it immediately. Congress has forced the FDA to collaborate with a drug�s manufacturer before a warning can be added to a package insert.
Drug company lawyers can veto any proposed warnings, said Larry Sasich, a Pennsylvania pharmacist and consultant for the consumer group Public Citizen.
�The agency has asked for more money and more authority,� Sasich said, �but Congress has refused to give it to them.�
Most of the FDA�s money and energy is spent on approving new drugs, Sasich said. But funding for surveillance � making sure existing drugs are safe � has remained flat for over a decade.
The FDA has a system, called MedWatch, for tracking problems with prescription drugs, but health officials are not required to report to it, so it captures only a tiny percentage of overdoses, he said.
Grassley and Sen. Christopher Dodd, D-Conn., have introduced a bill that would overhaul the FDA�s drug safety office and give it more independence and power within the agency. Rockefeller now plans to join as a co-sponsor of the bill, said spokeswoman Wendy Morigi.
The bill has been bottled up for more than a year in the Senate Committee on Health, Education, Labor and Pensions, whose chairman is Sen. Michael Enzi, R-Wyoming.
Grassley said the FDA could do more to warn the public, even without his bill.
�But legislation takes a long time, and the FDA has a moral and institutional responsibility to take action on its own, as well, to respond to the kind of data that�s resulting from these tragic deaths,� he said.
The FDA could send out a �public health advisory� warning doctors of the increase in methadone deaths, like it did recently for the drug fentanyl, Sasich said.
FDA spokeswoman Laura Alvey declined to say whether the FDA will issue a public health advisory about methadone.
Sasich said that under the current system, patients are left to fend for themselves too often. They have to educate themselves, because they cannot trust the agencies that are supposed to protect them.
�The patients have to know about it. They�re the ones at risk,� Sasich said. �Pharmacists, physicians and federal bureaucrats don�t get adverse drug reactions. Patients do.�
To read the rest of the series, The Killer Cure, go to www.wvgazette.com/section/Series/The Killer Cure
To contact staff writers Scott Finn and Tara Tuckwiller, use e-mail or call 357-4323 or 348-5189.