Lawmakers Questioning Scope of FDA Authority After Drug Safety Issues
A recent recall of more than 40 childrenâs over-the-counter medications by Johnson & Johnson subsidiary McNeil Consumer Healthcare has some lawmakers questioning whether FDA has enough authority to respond to drug safety problems, CQ Today reports.
McNeil last month recalled certain infant and children's over-the-counter medications after FDA identified manufacturing deficiencies in the company's Fort Washington, Pa., plant that could affect the products' potency, purity or quality.
According to CQ Today, the recall is the largest of children's medication in the history of FDA and the third major recall by McNeil in the past eight months.
Letters from Harkin, DeLauro
Senate Health, Education, Labor and Pensions Committee Chair Tom Harkin (D-Iowa) this week in a letter to FDA Commissioner Margaret Hamburg asked for information about the agencyâs investigation of the McNeil recall. FDA currently cannot mandate a recall of a drug product, though Harkin asked in the letter whether the agency could have encouraged a recall despite McNeil's objections. In the letter, Harkin asked nearly two dozen questions and set a June 11 deadline for them to be answered.
The letter follows a similar one sent to Hamburg by House Agriculture and FDA Appropriations Subcommittee Chair Rosa DeLauro (D-Conn.) earlier this month. It is unclear whether DeLauro or Harkin will hold hearings on the matter.
On Thursday, the House Oversight and Government Reform Committee is scheduled to hold a hearing to investigate the recall. Representatives from FDA and J&J are expected to testifyÂ Â (Ethridge, CQ Today, 5/25).
Lawmakers Say FDA Needs More Authority To Oversee Herbal Supplements
Meanwhile, other lawmakers have called for more authority for FDA to oversee herbal dietary supplements, the New York Times reports. The requests come after a recent report by the Government Accountability Office found that almost all supplements tested in a congressional investigation contained trace amounts of lead and other contaminants. The investigation also found that some sellers illegally claimed that their supplements can cure cancer or other diseases.
The results of the investigation will be examined on Wednesday during a hearing held by the Senate Special Committee on Aging.
The hearing comes two weeks before the Senate is set to debate a food safety bill that is expected to dramatically increase the agency's authority over food manufacturers. The legislation likely will require supplement makers to register annually with FDA and give the agency the authority to recall supplements suspected to be dangerous (Harris, New York Times, 5/25).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.