The Washington Post has reported that the Association of Boards of Pharmacy (ABP) has told State lawmakers that the group would like to see increased FDA regulations on large compounding pharmacies, similar to the ones which triggered last years meningitis outbreak. ABP’s director, Dr. Carmen Catizone, told the Senate Health committee that the ABP would welcome the “clarifications provided by the proposed legislation to the regulatory uncertainties that currently exist and were one of the primary factors leading to the meningitis tragedy.”
Last September, inspectors discovered unsanitary conditions at a Massachusetts compounding pharmacy. More than 50 people have died, and over 700 others have been sickened, by a wave of fungal infections that has been traced to the New England facility, which shipped more than 17,600 doses of the pain injection implicated in the outbreak. Regulators have gone on record as saying that the company was operating outside its state-issued pharmacy license when it manufactured tens of thousands of drug vials and shipped them without prescriptions.
These Compounding pharmacies produce customized injections, creams and other medications in formulas specified by doctors, and ship them all over the country. The pharmacies have traditionally been supervised by the 50 state boards of pharmacy across the entire U.S.. However, in recent years the boards have struggled to properly monitor the larger operations.
A Senate bipartisan committee has recently drafted proposed legislation that would label these operations “compounding manufacturers,” and would require them to register with FDA and meet the same quality control standards as other pharmaceutical giants. The bill will directly target giant compound pharmacy operations while leaving traditional compounding pharmacies (which are generally small operations that work directly with individual doctors) to be regulated by state pharmacy boards. Despite disagreements between Democrats and Republicans on how much power the FDA should be given over these “compounding manufacturers,” the final draft of the bill is scheduled to come out before Memorial Day says Senator Harkin, chairman of the Senate Health Education, Labor and Pensions Committee.
The FDA has also gone on record, saying that the bill is “a huge step in the right direction,” but also urged lawmakers to go further by granting the FDA unrestricted access to compounding pharmacies’ internal records (these records have traditionally only been subject to state pharmacy inspection).
Companies that engage in the pharmaceutical business must do everything that is in their power to ensure that they have taken all appropriate measures to secure the safety and efficiency of their product before it is distributed to the public. Sadly enough, many such companies are more concerned with their profit margins than the wellbeing of their clients. The Pavich Law Group P.C., has years of experience litigating against negligent and reckless businesses. If you believe that you have been harmed by a company’s negligent and reckless actions, please contact our experienced attorneys for a free consultation to determine your legal rights.