Markey has introduced a bill to increase regulation of compounding pharmacies after an outbreak of meningitis.
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.