San Francisco Product Liability Attorney Comments on Drug Safety Bill

The recent controversy over the safety of drugs and the rise in drug recalls prompted Colorado’s Senator Michael Bennet to introduce the Drug Safety and Accountability Act of 2010. The bill would give the FDA additional recall power and other investigative and enforcement options in the following ways: grant the FDA the authority to assess civil penalties for violations of the food Drug and Cosmetic Act and to subpoena documents and witnesses, facilitate the exchange of information between the FDA and other regulatory agencies, and protect the industry whistleblowers that wish to bring information to the FDA. The bill would also impose higher manufacturing standards by requiring companies to institute quality management plans to ensure the quality of safety of their drugs and drug components, including strong supplier oversight; and ensuring companies are able to document which entities are involved in the manufacturing supply chain for their drugs. Under the bill over the counter drugs (OTC’s) would be more closely scrutinized. Up until now the FDA has focused on prescription drugs and not OTC’s.
Medicine cabinets are full of pharmaceuticals and over the counter drugs, as most people have come to expect that the drugs they take will improve their health. They do not expect drugs to cause harm or death. Unfortunately the FDA’s approval of drugs has been called into question by a series of unfortunate events and created a crisis of confidence. During the past few years the FDA’s lack of oversight all the products that are marked under their regulation has placed American lives in jeopardy. This new bill would definitely help rebuild the FDA’s reputation. The bill would also force drug makers to bear a bigger regulatory burden. As such, pharmaceutical companies would have to documents their supply chains from start to finish-a prospect that probably isn’t happy about, since they believe their current efforts to protect consumer safety are sufficient. Here at the Brod Law Firm we are sure there will be plenty of debate over this bill and wonder if it will go anywhere. If you or a loved one has been injured from over the counter or prescription drugs, please contact us.

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