Instead of alerting the FDA and issuing a recall after discovering a quality problem with batches of Motrin, Johnson and Johnson hired contractors to go and buy up batches of the drug, instructing them to pretend to be regular customers and not to mention the word “recall.”
The House Committee on Oversight and Government Reform used this startling story in a hearing yesterday to illustrate and further probe the major quality and compliance problems that led to a massive recall of 136 million bottles of children’s medications last month.
At the hearing, Chairman Edolphus Towns (D-NY) and Ranking Member Darrell Issa (R-CA) pledged to introduce bipartisan legislation to give the FDA mandatory recall authority and additional powers to oversee drug safety issues. “One thing we know now is that the FDA needs mandatory recall authority,” Chairman Towns said. “They should not have to persuade a company to recall suspect products.”
The committee heard from both FDA Deputy Commissioner Dr. Joshua Sharfstein and Colleen Goggins, head of consumer products at J&J, which owns the division that made and recalled the drugs.
Sharfstein said that as the manufacturing problems go, those discovered at J&J were serious, and that the company’s delay in alerting the FDA was “deeply worrying.” Inspections of the now-closed plant Pennsylvania plant revealed that raw materials used in making the drugs had particles of nickel, chromium and cellulose, and some were contaminated with gram negative bacteria. Though batches using the raw material were not shipped, FDA said that the company shipped other parts of that lot, and did not do adequate testing to ensure their safety.
Asked about the authorities and resources the FDA needs to better safeguard the drug supply, Sharfstein frequently referred to the additional authorities in the pending food safety bill, which would give the agency authority to issue mandatory recalls, access company records, and assess civil penalties. (An FDA official said the J&J case had been referred to its office of criminal investigation.)
“This is a company that had a major problem with compliance,” Sharfstein said, “and I think in this case we did really call them to account for it.”
Thought the J&J plant is domestic, Rep. Issa (R-CA) rightly suggested that the incident raises larger questions about the safety of overseas manufacturing and imports, which are on the rise.
“I’m deeply concerned,” he said in his opening statement, “that J&J is the tip of the iceberg. If one of the most reliable and responsible organizations in America and a company with a great connections to the community can fail us, then what about those aspirins and other products that are more and more being imported from outside our country, from factories that are harder to reach. […]?”
Community Catalyst and Pew Prescription Project are concerned with these questions too, and support solutions that will shore up manufacturing safeguards and oversight in foreign and domestic plants.
While the chance that the contaminated batches caused illness was remote, Sharfstein said that the problem was a serious one and that the agency continues to look. “We consider these quality problems to be quite significant,” he said, “and want to fix them before it comes to the point where we’re counting the problem in hospitalizations and injuries, instead of bottles recalled.”
–Kate Petersen, PostScript blogger