Posted by Salvatore J. Zambri, founding member and partner
Following the recent debates over how to regulate the compounding pharmacy business, the Health, Education, Labor and Pensions Committee of the U.S. Senate has drafted a bill aimed to “make clear oversight responsibilities for pharmaceutical compounding and ensure safety for consumers.” According to the news as posted on the Committee’s Senate.gov website:
“Draft legislation preserves the states’ primary role in traditional pharmacy regulation and clarifies FDA authority over those making sterile products without prescriptions and shipping across state borders.”
As I have noted in earlier posts, the most challenging problem with compounding pharmacies has been determining who is in charge of regulating them. FDA Commissioner Margaret Hamburg indicated that the conflicting patchwork of state and federal laws regarding pharmacies has resulted in a lack of aggressive policing by the FDA. The new bipartisan Senate bill requires compounding manufacturers to register with the FDA, report the drugs they make, and meet standards similar to those of drug manufacturers.
The International Academy of Compounding Pharmacists has criticized the bill for creating “more confusion and blurring the jurisdiction authority of regulators.” Its position continues to be that states should license and oversee compounding pharmacies and that the FDA should oversee and regulate pharmaceutical manufacturers.
Public Citizen, a consumer advocate and nonprofit organization has also weighed in on the proposed Senate bill to regulate compounding pharmacies. In its press room release on May 1, 2013, “Public Citizen to Congress: Proposed Compounding Pharmacy Legislation Would Be a Major Step Backward for U.S. Drug Safety”, Public Citizen criticizes the bill for actually weakening existing FDA control and creating more ambiguity defining compounding pharmacies. An alternative suggested by Public Citizen proposes legislation that would:
“- Draw a single, clear line between traditional compounding and drug manufacturing, with no newly created category of second-tier, substandard drug manufacturers, called “compounding manufactures”;
– Provide adequate funding to the FDA to aggressively enforce existing laws against “compounding pharmacies” that cross the line into manufacturing;
– Strengthen the FDA’s authority to police the line between traditional compounding and drug manufacturing by requiring registration and granting the FDA authority to inspect for traditional compounding pharmacies, regardless of whether they engage in drug manufacturing activities; and
– Require clear, standardized warning labels to communicate to providers and patients who purchase traditional compounded products that the safety, efficacy and the accuracy of the product’s labeling have not been assessed by the FDA.”
Obviously, compounding pharmacy regulation has become a hot button topic that I will continue to follow and update for our readers. The good news is that the safety problems of compounding pharmacies are finally receiving some high-level attention.
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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 (2013 edition) acknowledged as one of the “Best Lawyers in America” by Best Lawyers in both medical malpractice and personal injury law, and has also been repeatedly named a “Super Lawyer” by Law and Politics magazine (2013)–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.