Rule aims at averting drug shortages

The Obama administration issued an interim final rule requiring drug companies that are the sole producer of certain critical drugs to report all product manufacturing interruptions to the Food and Drug Administration.

Prior to the interim final rule, legal notification was required when production of a critical drug manufactured by only one company was being discontinued. The announcement follows an executive order issued by President Barack Obama on Oct. 31 that encourages manufacturers to voluntarily notify the FDA about potential prescription drug shortages.

“We will continue to take steps such as issuing this interim final rule to prevent and reduce current and future disruptions in the supply of lifesaving medicines,” said FDA Commissioner Dr. Margaret Hamburg in a news release.

As scrutiny about the record number of drug shortages has increased in Washington, a growing number of lawmakers and healthcare associations have called for stricter notification requirements for manufacturers.

Bills in the House and Senate would require manufactures to notify the FDA in advance of potential causes of shortages. The American Medical Association, which supports the drug-shortage legislation, adopted a drug-shortage policy in November that states the group will advocate that Congress or the FDA require manufacturers to establish continuity plans for certain drugs.

The Generic Pharmaceutical Association proposed creating a voluntary communication system in which an independent third party would provide real-time supply and distribution information to manufacturers, wholesalers, distributors, GPOs and the FDA. The initiative would increase visibility about shortages between industry and the FDA, according to the trade group. It would also require acceptance by the Federal Trade Commission and HHS.

In addition, today the Government Accountability Office released its report on drug shortages and Sens. John Rockefeller (D-W.Va.) and Tom Harkin (D-Iowa) said in a news release they would join Rep. Elijah Cummings (D-Md.) in his investigation into secondary drug distributors, some of which have been accused of price speculation while buying and selling drugs in short supply.

The lawmakers said they issued a third letter to Superior Medical Supply requesting information about the Superior, Colo.-based secondary distributor's purchases and sales of paclitaxel, a oncology drug in short supply.

They also said they contacted Hospira for information about the company's decision to end its authorized-vendor relationship with Superior Medical Supply in October, as well as any other distributor relationships that ended as a result of similar reasons.

The GAO found that 12 of the 15 drug shortages (PDF) reviewed for its report were caused by manufacturing problems. The report also found that the FDA is “constrained by its lack of authority to require manufacturers to provide the agency and the public with information about shortages, or require that manufacturers take certain actions to prevent, alleviate, or resolve shortages.”