FDA seeks more control of compounding pharmacies
The outbreak that has led to 438 infections, including 32 deaths, can be blamed in part on a patchwork of state regulations for compounding pharmacies that restrained federal officials from intervening, Food and Drug Administration Commissioner Margaret Hamburg told members of a House subcommittee in Washington on Wednesday. She asked for greater federal power to inspect the pharmacies and test their medicines.
"We ought to work on using the authority that we have as opposed to getting additional authority at the federal level," Rep. Joe Barton, R-Texas, responded.
Hamburg's characterization of her current authority as complex and her insistence that the FDA is held back by law from overseeing such specialty pharmacy operations, led to visible frustration by Barton and other lawmakers. They questioned whether the FDA could have shut down the pharmacy at the center of this year's meningitis outbreak, New England Compounding Pharmacy, based on incidents dating as far back as 2002.
"We're not buying it, Dr. Hamburg," said Rep. Michael Burgess, R-Texas, during the hearing of the House Energy and Commerce oversight subcommittee. "We're just not buying it."
Lawmakers cited an FDA warning letter to New England Compounding Pharmacy, known as NECC, in 2006 in which the agency said it could shut down the business if the pharmacy failed to correct business practices that involved copying certain drugs without permission.
In addition, inspection reports show that the risk of illness from drugs produced at NECC was known by the FDA as early as 2002. The pharmacy suspended operations on Oct. 3 of this year and recalled 17,676 doses of the pain-killing steroid methylprednisolone acetate after regulators determined that tainted vials of the therapy were responsible for fungal meningitis infections in 19 states.
Rep. John Dingell, D-Mich., said both the FDA and officials in Massachusetts, where NECC is based in Framingham, "dropped the ball."
Hamburg confirmed to lawmakers that the FDA is pursuing a criminal investigation into NECC. The Justice Department also is investigating the company.
Hamburg argued that compounding pharmacies should face increased oversight based on their size. Compounders that mix drugs on a large scale in anticipation of prescriptions, rather than adhering to the traditional role of responding to individual doctor's orders, should register with the FDA, Hamburg said in prepared remarks for the hearing.
Rep. Tim Murphy, R-Penn., reminded Hamburg that Massachusetts had "cleaned house" recently and gotten rid of pharmacy officials who hadn't done their job and investigated complaints from Colorado that NECC was acting like a manufacturer.
Massachusetts regulators have moved to permanently revoke the license of the pharmacy, citing business practices that may have exceeded the scale and scope than is typically allowed.
"Why did so many medical providers purchase this product from unregulated or poorly regulated sources?" Joyce Lovelace, the widow of a meningitis victim, asked lawmakers at the hearing. "Don't just investigate. Instead, legislate and regulate."
NECC co-owner Barry Cadden, who appeared Wednesday, declined to answer questions from lawmakers, citing his constitutional rights. The Senate's health committee plans a hearing Thursday on compounding pharmacies that will feature representatives of the drug industry, as well as Hamburg.
The FDA plans to meet Dec. 19 with state officials to determine how to best regulate compounding pharmacies, Hamburg said during the hearing.
Hamburg suggested traditional compounding pharmacies stay largely under state control with the FDA being able to have more inspection authority. "Non-traditional" compounders, such as those that mix sterile products like the injectables NECC made, should have to register with the FDA.
Copies of FDA approved drugs, complex dosage forms such as extended release products and most biologics, which are made from living organisms shouldn't be compounded, Hamburg said, with the exception that the FDA may allow copies to be mixed when there is a shortage.
The latest meningitis outbreak occurred even as FDA inspection records from 2002 showed that NECC may not have met standards for sterility then, and that a hospital in Rochester, New York, at the time linked NECC's methylprednisolone acetate to meningitis-like symptoms in two patients.
"I was stunned and angered to learn that an inspection of the NECC by the FDA and the Mass Board over 10 years ago identified contamination in the very same drug at issue in the current outbreak," said Rep. Fred Upton, R-Mich., chairman of the House Energy and Commerce Committee. "Ten years later, we are in the midst of an unthinkable, worst-case scenario."
Meningitis is an inflammation of the lining of the brain and spinal cord. The government has said about 14,000 people received shots of the NECC steroid, which is injected into the spinal cavity to relieve neck and back pain.
The FDA is asking for strengthened authority as additional missteps by Massachusetts officials were revealed in prepared remarks from Lauren Smith, interim commissioner of the state's Department of Public Health.
Cadden served on a task force convened by the Massachusetts Board of Registration in Pharmacy in 2002 to study oversight of compounding pharmacies. While the group met for about two years, it appears never to have made any recommendations, Smith said.
In addition, the pharmacy board's executive director and counsel learned in April 2006 that the executives at the auditor hired to oversee the sterility operations of NECC after the pharmacy was flagged for safety violations had been convicted of federal crimes for defrauding the FDA.
They didn't pass the information on to the pharmacy board, Smith said, and the board told Cadden two months later NECC had satisfactorily completed the terms and conditions of a consent agreement.
Smith said she supported legislation that gave the FDA more power over compounding pharmacies, though she didn't comment specifically on Hamburg's proposal.
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