New legislation that would place manufacturers of compounding drugs under Food and Drug Administration (FDA) supervision recently passed House and Senate committees and has been sent to Congress for consideration.
The Pharmaceutical Compounding Quality and Accountability Act (S. 959) is sponsored by U.S. Sen. Tom Harkin (D-IA) and co-sponsored by Sens. Lamar Alexander (R-TN), Al Franken (D-MN), Barbara Mikulski (D-MD), Pat Roberts (R-KS), and Elizabeth Warren (D-MA). If passed, the bill would amend the Federal Food, Drug, and Cosmetic Act to include compounding drugs and place manufacturers under the more rigorous quality standards and drug safety oversight of the FDA.
The legislation is in response to multiple adverse events that have been tracked to large-scale compounding pharmacies, which to date are regulated by the states in which they manufacture. The most serious case is a 2012 outbreak of fungal meningitis that led to the deaths of more than 50 people who took injectable steroid solutions. Since the outbreak, dozens more compounding companies have been found to be producing and selling drugs that were contaminated or created in unsafe conditions.
Although rheumatologists commonly prescribe corticosteroids for their patients, Michael H. Weisman, MD, director of the division of rheumatology at Cedars-Sinai Medical Center in Los Angeles, says he has never prescribed them from a compounding pharmacy and thinks the practice is “uncommon.” Even so, he agrees the fungal meningitis outbreak “is a very bad result.”
“It is important for something like this to have FDA regulation,” says Dr. Weisman, a member of the ACR Drug Safety Subcommittee and former member of the FDA Arthritis Advisory Committee. “When you are dealing with injectable drugs, the quality controls should not be left up to the states to regulate.”
Richard Quinn is a freelance writer in New Jersey.
