In 2010, the US House of Representatives’s Committee on Oversight and Government Reform held two hearings after scandalous cGMP violations at McNeil’s Puerto Rico facilities came to light. Former FDA Deputy Commissioner Joshua Sharfstein told the Committee that the agency would review McNeil’s plan for correcting deficiencies to ensure that the corrective actions were effective. “FDA intends to keep a close eye on these facilities until the company earns our confidence back,” said Sharfstein.
But when Committee Chair Representative Darrell Issa (R-CA) recently visited Maridalia Torres, FDA’s Puerto Rico district director, he learned that neither she nor her staff had visited the McNeil facilities since the time of the hearings. What’s more, Torres had not evaluated McNeil’s corrective actions, but had relied on a third-party compliance officer—hired by McNeil—for information. In a letter to FDA Commissioner Margaret Hamburg, Rep. Issa asked whether FDA had taken any disciplinary actions against its Puerto Rico employees.
Last week, Senators Charles Grassley (R-IA) and Max Baucus (D-MT) expressed concerns about the way FDA oversees the citizen-petition process. As the agency was considering the approval of generic alternatives to Sanofi’s Lovenox blood thinner, it reviewed letters from a professor and two medical groups requesting that approval be delayed. At Congress’s request, Sanofi produced documents revealing that it had encouraged the groups to write to FDA. The company paid the two groups more than two million dollars each, and paid the doctor more than $200,000. None of these three parties revealed their financial relationship with Sanofi to FDA in their letters. And FDA apparently did not ask.
In their letter, the senators warned that abuse of the citizen-petition process could delay patient access to “potentially affordable, safe, and effective generic alternatives.” The lawmakers asked what steps FDA had taken to ensure that the process was transparent.
No government agency is perfect, and FDA does suffer from a chronic shortage of resources. But if FDA is at fault in these two incidents, it is because of a lack of diligence rather than a lack of funds. Patients, whose lives are at stake, need the agency’s protection. I hope FDA rises to the challenge of Congress’s tough questions.