Sen. Harkin has 'high hopes' for drug safety bill

WASHINGTON — The chairman of the Senate Health, Education, Labor and Pensions Committee highlighted the human tragedy wrought by last year's fungal meningitis outbreak linked to contaminated injectable steroids as he spoke in favor of a new law that would regulate compounding pharmacies and implement federal track-and-trace policies for drugs during a recent speech.

Sen. Tom Harkin, D-Iowa, expressed "high hopes" that the Senate would vote to enact the Drug Quality and Security Act, which is designed to ensure the safety of compounded drugs and secure the pharmaceutical supply chain and was cosponsored by Senate HELP Committee ranking member Lamar Alexander, R-Tenn. The bill has received support from the National Association of Chain Drug Stores, the National Community Pharmacists Association and the Generic Pharmaceutical Association.

"The 751 patients who were sickened by contaminated injections sold by [the New England Compoundint Center] and the families of the 64 who have died have lived a nightmare over this past year," Harkin said in the speech. "The medicine that was supposed to help them made them gravely ill or, in far too many cases, took their lives."

Harkin highlighted the cases of four patients who have had to quit their jobs due to unrelenting chronic pain, whose children have had to quit their jobs to take care of them, or who have lost their lives. He called the compounding provisions in the legislation an "unqualified step forward" from current law and practice, emphasizing that it distinguishes between traditional compounding and compounding that produces large volumes of drugs without individual prescriptions. Under the law, compounding pharmacies that perform such outsourcing services would be subject to Food and Drug Administration regulations, while those that engage in traditional compounding would continue to be regulated by the state boards of pharmacy.

Meanwhile, the bill's track-and-trace provisions "will revolutionize the pharmaceutical supply chain," Harkin said, saying it would complete the work of last year's FDA user-fee bill, which includes provisions to modernize the FDA's authority regarding the so-called upstream supply chain, meaning the path of drugs from raw materials to finished products. The new bill, Harkin said, would modernize the downstream supply chain, meaning the path drugs take from manufacturers to providers and patients.

"The last comprehensive effort to establish safeguards for the drug distribution supply chain was 25 years ago," Harkin said.