Harkin Statement on HELP Committee Passage of the Pharmaceutical Compounding Quality and Accountability Act and the Drug Supply Chain Security Act

WASHINGTON—Today, Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, issued the following statement on the Committee’s passage of S. 959, the Pharmaceutical Compounding Quality and Accountability Act, and S. 957, the Drug Supply Chain Security Act.

“I am pleased that the HELP Committee has come together in a bipartisan effort to protect the public health from tainted and adulterated prescription drugs. These bills will enable Americans to be confident that the bottles in their medicine cabinet contain exactly what the doctor ordered.

“The Pharmaceutical Compounding Quality and Accountability Act will clarify oversight of pharmaceutical compounding, leaving traditional pharmacies under the supervision of states, while enabling the U.S. Food and Drug Administration to regulate compounding manufacturers, companies that make compounded sterile drugs without prescriptions, and ship them across state lines. This change will grant FDA the authority it needs to help protect Americans against future tragedies, like the meningitis outbreak—caused by tainted compound steroid injections—that claimed more than fifty lives in 2012.

“The Drug Supply Chain Security Act will strengthen the FDA’s ability to track prescription drugs after they leave manufacturers, ensuring that they are accounted for at every step. That way, doctors, patients, and regulators can be sure that their medicines are safe.”

“I plan to work with Senate leadership to bring this bipartisan legislation to the floor for a vote in a timely manner.”

###