The committee also invited FDA Commissioner Margaret Hamburg, Massachusetts Department of Public Health Interim Commissioner Lauren Smith, and president and co-owner of the New England Compounding Center Barry Cadden to testify. However, Mr. Cadden invoked his Fifth Amendment rights and refused to answer any questions.
The purpose of yesterday’s hearing was to determine whether this tragedy could have been prevented. We need to determine what went wrong to ensure no one else suffers the same pain the Lovelace family and 31 other families experienced. Unfortunately, more questions than answers resulted from yesterday’s hearing.
The FDA’s spotty history with the NECC dates back to 2002, when state and federal regulators initially found contaminated drugs. Despite this initial red flag, the regulators were slow to act and the company’s doors remained open. In fact, it took four years after finding problems with the NECC’s sterility practices and violations of the Food, Drug and Cosmetic Act to issue a warning letter. However, the letter served as nothing more than an empty threat, since the FDA failed to follow-up to ensure the company corrected the violations.
Several members questioned the FDA’s failure to shut down the NECC’s operations sooner. FDA Commissioner Hamburg repeatedly asserted that the FDA lacked the necessary authority to do so. Hamburg’s response raised additional questions from members, such as: if the FDA had the authority to shut down the NECC in October of this year, why didn’t it assert its authority in 2006?
Prior to the hearing, the committee requested the FDA provide all documents related to FDA’s oversight of the NECC. Unfortunately, the FDA has still not provided a critical timeline, or communications relating to the NECC. When Rep. Marsha Blackburn (R-Tenn.) questioned whether FDA followed up on a recorded complaint, Commissioner Hamburg suggested there was email traffic regarding how the complaint was handled. However, Interim Commissioner Dr. Lauren Smith of the Massachusetts Department of Public Health stated that the Board was unable to find any evidence that FDA contacted them about the complaint.
Officials at the Massachusetts Department of Public Health have been quite cooperative, providing thousands of pages of documents to the committee, and yet, the FDA has not turned over a single email in response to our request.
It’s time for the FDA to provide the internal documents requested nearly a month ago. We cannot fix the problem until we know what part of the system is broken. I would encourage the FDA to start cooperating and provide the documents the committee seeks, rather than continue to focus its efforts on self-preservation. It is my sincere hope that we will learn from these mistakes so that history does not repeat itself. We owe it to Mrs. Lovelace, her family, and every single family affected by this preventable tragedy.
Stearns is chairman of the Oversight and Investigations Subcommittee.