Legislation, known as the SAFE Compounding Drugs Act, was introduced Wednesday, December 5, 2012, in the U.S. House of Representatives by Congresswoman Rosa DeLauro (D-Conn.) and Congresswoman Nita Lowery (D-New York). The bill, if passed, would require drug compounding companies to register with the U.S. Food and Drug Administration (FDA), adhere to minimum production standards set by the FDA and to new labeling restrictions on compounded drugs. A bill introduced in November by Congressman Ed Markey (D-Mass.) also addressed the scope of FDA’s authority vis à vis companies that compound drugs.
These new pieces of legislation follow on the heels of the fungal meningitis outbreak, the public health disaster caused by contaminated steroid injections compounded and distributed by the New England Compounding Center (NECC) this past fall. The contaminated injections sickened at least 541 people and killed 36, according to the U.S. Centers for Disease Control and Prevention (CDC). The outbreak brought to light the lack of scope of FDA’s authority and the weaknesses in rules, both state and federal, that applied to drug compounding companies. It is disappointing, according to a Reuters article of December 5, 2012, that Congress will probably not vote on this legislation during this session. (Why? This should be a slam dunk.)
Critics are calling for stronger federal regulation of the compounding facilities—even the FDA wants to revise the standards to include oversight of large drug compounding operations. The drug industry lobby appears to have blocked giving broader authority to the FDA where compounding facilities are concerned. The NECC had been on the FDA’s radar with problems dating back ten years prior to this health crisis. While that company has ceased operations, there are still patients who received the injections who continue to be monitored.
The drug lobby needs to be ignored on this issue (along with many others), because we have verifiable evidence of a failure, at multiple levels, of the industry and the system. How many people need to die before Congress actually passes effective measures, ignoring the money and lobbying efforts of Big Pharma?