Bill Seeks to Arm FDA with Full Drug Recall Power And More Over the Counter Regulatory Control
Posted Aug 05 2010 6:56am
This looks like some of the areas I have been writing about in reference to recall matters and the safe shipping and documentation of drugs. The bill would also give the FDA authority to recall and not just send warning letters out asking for recall, they would be able to actually police the efforts. If you remember the Heparin problem, use the link below and see what I suggested over a year ago with using technology. I spent many years in the logistics business and there are what is called a “blind shipment” so you have go back and trace the data trail as the actual product may only list the drug company’s headquarters and the same happens on bills of lading too in some instances.
In addition a group of servers could be set up to receive information on each lot for compliance and quality control. That would also help direct agents from the FDA on where to search as well for problems. More on blind bills of lading below as this pertains to both food and drugs.
As you can read, currently the FDA sends letters and recommends recalls and most cooperate but this would give the FDA first hand authority to demand. You can read below how the same technology would help identify counterfeit drugs too so if the bill goes through, we would have a better working relationship with technology shared between the DEA and FDA for enforcement too, good thoughts here. There’s a permanent link at the top of the blog to find a large summary on the topic.
If Congress is going to pass the bill, then give the government agencies and all others concerned the technology tools to make this work and not just a big stack of text that everyone spends hours trying to interpret. BD
A newly proposed bill intends to empower the Food and Drug Administration with the authority to recall potentially dangerous drugs. The Drug Safety and Accountability Act of 2010 was introduced by Colorado Senator Michael Bennet this week. Currently, the FDA can issue warnings about safety concerns of a certain drug and then recommend that the manufacturer initiate a recall. If the bill passes, the regulatory agency will have the power to recall drugs it considers to be dangerous.
The bill also seeks to strengthen drug manufacturing standards and closely track their pathway into the U.S. It would require companies to implement quality management plans and mandate more rigorous documentation processes for the origins and handling of imported drugs.
Many legislators have expressed concern over the lack of FDA authority over drug regulation. In a letter to the FDA commissioner in May, Iowa Senator Tom Harkin, the chairman of the Senate Committee on Health, Education, Labor and Pensions, asked the agency if “as a public health agency whose mission is to protect the American public, you have sufficient authority to prevent and respond to contamination of the drug supply.”