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Meningitis Hearings Will Examine Role of Regulators

The company that made a contaminated drug causing a meningitis outbreak and the regulators in charge of overseeing it will all be under scrutiny during two committee hearings this week.

A House Energy and Commerce subcommittee and the Senate Health, Education, Labor and Pensions Committee will question the company’s business practices and whether federal and state investigators took appropriate action given the company’s record of violations.

The hearings could prompt legislative action to increase oversight of compounding pharmacies such as the one linked to the outbreak. Subcommittee member Rep. Edward J. Markey, D-Mass., has introduced a bill (HR 6584) to increase the Food and Drug Administration’s regulation of compounding pharmacies, and Rep. Rosa DeLauro, D-Conn., plans to introduce a measure soon.

Both panels will hear from Margaret A. Hamburg, commissioner of the FDA; Lauren Smith, interim commissioner of the Massachusetts Department of Public Health; and Barry Cadden, owner of the New England Compounding Center. Last week, Energy and Commerce Chairman Fred Upton, R-Mich., issued a subpoena for Cadden to testify after he declined to appear.

Cadden’s company made an injectable steroid drug that became contaminated, leading to an outbreak of fungal meningitis. The outbreak has caused 438 cases and 32 deaths, according to the Centers for Disease Control and Prevention.

The company, which has voluntarily recalled all its products, has a long history of reported infractions, according to a background memo from the Energy and Commerce Committee.

The memo says inspectors from the FDA and Massachusetts, where the firm is located, found deficiencies with the company’s practices for years. As early as 2002, regulators found the company did not have sufficient safeguards to ensure the sterility of its injectable drugs.

The FDA conducted three series of inspections of the NECC between 2002 and the most recent outbreak, and issued a warning letter in 2006 noting problems in the company’s business practice.

In addition, the Massachusetts Board of Registration in Pharmacy investigated at least 12 complaints involving the NECC or Cadden, the committee said.

The New England Compounding Center appears to occupy a gray area between compounding pharmaceuticals and manufacturing, where the FDA and state regulators divide oversight. The FDA has some authority over traditional compounding pharmacies but tends to leave oversight to the states.

The House committee memo says the Nov. 14 Subcommittee on Oversight and Investigations hearing will address whether the regulators took appropriate enforcement actions, given the problems at the NECC. It will also look into what authorities did to ensure the company took corrective actions following inspections.

For example, the memo says lawmakers will explore why the company kept its pharmacy license despite violations found by the Massachusetts regulators, including problems associated with serious adverse events from the company’s products.

The committee memo notes that the FDA did not reply to Cadden’s response to the 2006 warning letter until Oct. 31, 2008. That is the last documented correspondence between the agency and the company until the recent outbreak, the memo says.

In addition, it notes that the company’s facility passed a Massachusetts pharmacy board inspection in May 2011.

That same month, the FDA’s Denver and New England district offices were corresponding about the company’s illegal distribution of compounded pharmaceuticals to Denver hospitals. However, the FDA did not contact the Massachusetts Board of Pharmacy about the violations, the committee memo says.

In July, a Colorado Board of Pharmacy inspector told James Coffey, director of the Massachusetts pharmacy board, that the NECC was violating terms of a cease and desist order the state had issued in April 2011.

Coffey did not take any enforcement action or order an investigation. Officials at the Massachusetts Department of Public Health said they became aware of the complaint only when reviewing documents for the committee’s investigation. Coffey, who had been invited to testify at the House subcommittee hearing, was fired Nov. 6.

Also testifying at the Senate hearing Nov. 15 will be Beth Bell, director of the Center for Emerging and Zoonotic Infectious Diseases at the CDC; David G. Miller, executive vice president and CEO of the International Academy of Compounding Pharmacists, and Kasey K. Thompson, vice president of the Office of Policy, Planning, and Communications at the American Society of Health System Pharmacists.

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