New legislation has been introduced that would give the FDA increased powers and reach to manage and ensure the security of the nation’s drug supply.
On Tuesday, Senator Michael Bennet, of Colorado, introduced the Drug Safety and Accountability Act of 2010, which would increase the FDA’s regulatory authority over drugs. The bill comes after a number of high-profile incidents dealing with unsafe medications and drug recalls.
The bill, if passed, would give the FDA the power to recall drugs that it believes are dangerous. Currently, the FDA can only warn that a drug is unsafe and recommend that a manufacturer recall the drug. The manufacturer voluntarily agrees to remove the drug from the market. The bill would also allow the FDA to track the increasingly complicated and intricate supply lines for drug companies, so that it would know the supplier for every ingredient.
One of the problems, according to supporters of the bill, is the growing complexity of the drug supply chain, which can make it difficult to know where drugs originated. In 2007 and 2008, about 100 people were killed by counterfeit Heparin manufactured in China. And late last year, there was a Yaz recall after the FDA found that it was possible that Bayer shipped substandard birth control pills to the U.S. from a production plant in Germany.
The bill also comes amid increasing congressional interest in boosting FDA’s power. In 2009, there was a record 1,742 drug recalls, four times as many as there were in 2008. There were also a number of incidents that got congressional attention, such as Johnson and Johnson’s liquid children’s drug recall earlier this year. Following that recall and FDA allegations of quality control problems within the company’s McNeil Healthcare unit, a number of lawmakers inquired whether the FDA had enough power to adequately safeguard the nation’s drug supply.
Lawmakers have also been paying attention to the ongoing controversy over the diabetes drug Avandia, which some say has caused more than 100,000 deaths and heart attacks. In a congressional Avandia report released in February, Senators castigated drug maker GlaxoSmithKline for allegedly downplaying the risks of Avandia and allowing it to remain on the market despite Avandia side effects.
Lobbyists for drug manufacturers appear to be poised to fight the bill, saying that the FDA has enough power already, and that the U.S. has the most stringent drug laws in the world.
However, the push to increase FDA power is gaining broad support. The American College of Physicians, the AARP, the Consumers Union and the Society of Chemical Manufacturers and Affiliates have all stated their interest in supporting new measures to give FDA greater authority over the drug supply chain.