Rep. Bono Mack slams FDA over drug recalls

By Julian Pecquet - 01/17/12 04:01 PM ET

Rep. Mary Bono Mack (R-Calif.) on Tuesday accused federal regulators of being asleep at the switch when they failed to issue a recall of mislabeled painkillers.

Bono Mack said the agency knew about problems at a Novartis manufacturing facility in Nebraska for years but failed to take action until the drugmaker voluntarily closed its facility and issued a recall for over-the-counter medications in the past few weeks.

The facility has received 12 citations for quality-control problems and 166 complaints of mixed pills in bottles since 2009, Bono Mack said.

"I am outraged at the lack of leadership shown by FDA to guarantee the safety of patients across the country, and it perplexes me that inspectors continued citing problems with the facility without holding Novartis accountable," Bono Mack wrote in a letter to FDA Commissioner Margaret Hamburg. "If FDA had taken a more proactive, consistent role in the ongoing inspections, the recall by Novartis could have been avoided and consumers would not be at risk of accidentally taking prescription painkillers in place of over-the-counter drugs such as Gas-X."

A spokeswoman for the FDA said in an e-mail that the agency "did not believe that a recall was warranted because of the following reasons:

• Given the very low risk of a medication mix-up, and that these are medically necessary products, this approach should also help to mitigate to some degree the likely shortage of these products given the manufacturing issues at the Lincoln, Nebraska facility.

• For prescription opioids the pharmacist serves as a second level of protection against such mix-ups. In many, if not most, cases the dispensing pharmacist would have counted the tablets and would likely have identified any stray tablets prior to dispensing to a patient; and

• FDA and Endo Pharmaceuticals are recommending additional steps to further reduce the already low risk of a medication mix-up by having patients and pharmacists check tablets.

"It is also important to note that for Novartis OTC products, FDA has concluded that we have no reports of adverse events related to product mix-ups stemming from errant product."

Bono Mack, a high-ranking member of the Energy and Commerce Committee, is a leader of congressional efforts to limit painkiller overdoses, which now surpass the numbers of deaths from cocaine and heroin combined.

Update: This post was updated at 5 p.m. with comment from the FDA