Legislation that was introduced earlier this week is of particular interest to those companies in the life sciences industry. The bill, titled the Drug Safety and Accountability Act of 2010, DrugSafetyandAccountabilityAct, would give the FDA increased regulatory authority over drugs.
The proposed legislation is intended to boost consumer protection against adulterated drugs by establishing quality standards for the FDA, drug companies and their contractors--who are increasingly based overseas where safeguards may be lower than those of the U.S. The legislation also would improve the federal government’s tracking systems of manufacturing sites. If passed, it also would give the FDA the authority to require a company to recall drugs that have been found to be contaminated or unsafe.
Supporters of the bill cite the growing complexity of the drug supply chain as the chief problem. It is that complexity that makes it difficult to know where drugs or ingredients originated. That complexity, along with the rapidly rising number of high-profile incidents and general wariness of consumers regarding product safety, have prompted some lawmakers to wonder whether the FDA actually has enough power to adequately safeguard the nation’s drug supply.
For instance, in 2007 and 2008, there were approximately 100 deaths attributed to taking contaminated Heparin that was produced in China. Additionally, last year, there was a Yaz recall after the FDA determined that it was possible that Bayer shipped substandard birth control pills to the U.S. from a production plant in Germany.
It isn’t always the drugs themselves that are the source of the recall. Sometimes it’s the packaging materials that are potentially unsafe. Either way, it’s ultimately the manufacturer’s responsibility.
A couple of weeks ago, I wrote about McNeil Consumer Healthcare’s recall of 21 lots of over-the-counter drugs sold in the U.S., Puerto Rico, Fiji, Guatemala, the Dominican Republic, Trinidad and Tobago, and Jamaica, FulcherblogRecalls. Those drugs include Benadryl, Children's Tylenol, Motrin IB, Tylenol Extra Strength, Tylenol Day & Night and Tylenol PM.
That recall actually is a follow-up to a large recall of those drugs earlier this year that was initiated following consumer complaints of a musty or moldy odor. The odor has been linked to the breakdown of a chemical applied to the wooden pallets used to transport and store the products’ packaging materials--and has been traced to a facility in Puerto Rico. The newly recalled lots apparently used packaging materials that had been shipped and stored on the same type of wooden pallet.
As for the latest proposed legislation, it’s important to note that the push to increase FDA power doesn’t just come from lawmakers. Indeed, the American College of Physicians, the AARP, the Consumers Union and the Society of Chemical Manufacturers and Affiliates submitted a jointly written letter to congress backing the bill. jointlettertoFDA.
Lobbyists for drug manufacturers are preparing to oppose the bill. They are sure to argue that first of all, the FDA already has sufficient power. They’ll also point out that the U.S. has the most stringent drug regulations in the world.
In any event, I’m interested in how all this plays out. What are your thoughts on the bill, the FDA’s current capabilities, and the impact a product recall has on your business?