Posted by Salvatore J. Zambri, founding member and partner
After so many cases and deaths related to the New England Compounding Center’s tainted steroid shots, new inspections have resulted in a report about conditions and practices that violated federal law aimed at maintaining sterile environments. Sarah Sellers, a former FDA official who is now a consultant on quality and sterility issues, also reviewed the report. “The entire pharmacy was an incubator for bacteria and fungus,” she said. “The pharmacy knew about the contamination and did nothing.”
However, a more recent review of compounding pharmacy practices shows that these organizations have been tied to deaths and illnesses over the past decade and that those pharmacies have experienced safety problems for years. According to a recent Washington Post article, compounding pharmacies “mass-produce medications and ship them across state lines, often without individual patient prescriptions.” Compound pharmacies supply about 40% of all intravenous medications used in hospitals and are not required to follow the safety rules that apply to commercial drugmakers. With such a lightly-regulated industry, neither state nor federal authorities did much to “systematically inspect and correct hazards posed by specialty pharmacies,” resulting in practically no punishment for the pharmacies, even when their mistakes caused deaths.
As further indication that this problem has been known for some time: “In 2007, a team of investigators from the Centers for Disease Control and Prevention issued an unusually blunt warning to hospitals and doctors: Compounded drugs had a higher risk of contamination than commercially manufactured drugs, and compounding pharmacies had ‘generally lower quality-control standards than pharmaceutical manufacturers.’ ”
The FDA has pressed Congress for more authority to regulate compounding pharmacies. FDA Commissioner Margaret Hamburg said, “Legislation is needed that would allow the FDA to routinely inspect ‘non-traditional’ compounding pharmacies, hold them to higher production standards and see records about the volume of drugs being made, as well as require compounders to report adverse events associated with their products.” State pharmacy boards have the primary responsibility for policing the compounding pharmacies, but they have an uneven record of enforcement. In addition, the regulatory standards that do exist for the compounding pharmacy industry has not kept pace with the rapid expansion pace of that business. By relying on gaps in laws and conflicting court rulings, these companies have fought enforcement orders and kept the FDA out of their facilities.
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About the author:
Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the ” 2011 Trial Lawyer of the Year“. He has also been acknowledged by Washingtonian magazine as a “Big Gun” and among the “top 1%” of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as “one of Washington’s best–most honest and effective lawyers” who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2012 edition) acknowledged as one of the “Best Lawyers in America” by Best Lawyers, and has also been repeatedly named a “Super Lawyer” by Law and Politics magazine (2012)–a national publication that honors the top lawyers in the country.
Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.
If you have any questions about your legal rights, please email Mr. Zambri at [email protected] You may also reach him at 202-822-1899.