Read as much as you want on BostonGlobe.com, anywhere and anytime, for just 99¢.

FDA chief will testify at first meningitis hearing

FDA Commissioner Dr. Margaret Hamburg

Reuters File/2010

FDA Commissioner Dr. Margaret Hamburg

WASHINGTON (AP) — House lawmakers investigating a nationwide outbreak of deadly meningitis have summoned the head of the Food and Drug Administration to testify at the first congressional hearing on the issue next week.

The Energy & Commerce Committee said Monday that FDA Commissioner Dr. Margaret Hamburg will appear before the committee on Nov. 14.

Continue reading below

The Centers for Disease Control and Prevention has reported 419 cases of meningitis illness linked to contaminated steroid shots distributed by New England Compounding Center. Thirty people have died as a result of the outbreak, the agency reported Monday.

Committee staffers said they have also invited Barry Cadden, co-founder of the specialty pharmacy linked to the outbreak. Also invited is James Coffey, director of the Massachusetts Board of Registration in Pharmacy. Staffers say they are awaiting replies from Cadden and Coffey.

Compounding pharmacies traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. But some pharmacies like the NECC have grown into much larger businesses in recent years, supplying bulk orders of medicines to thousands of doctors and hospitals across the country.

Continue reading it below

In recent weeks, inspectors from the FDA and Massachusetts department of health have reported unsterile conditions at the Framingham, Mass. pharmacy’s facilities. The most recent inspection from the FDA uncovered green and yellow residues, water droplets and standing water in or around production rooms that were supposed to be sterile.

House and Senate lawmakers have called for hearings to examine how the outbreak could have been prevented.

Compounding pharmacies have long operated in a legal gray area between state and federal laws. All pharmacies, including compounding pharmacies, have long been regulated by state pharmacy boards. However, the FDA has attempted to exercise its authority in cases where major problems have arisen. In several instances, federal courts have ruled that the agency overstepped its bounds.

FDA officials said last month that new laws may be needed to clarify the federal government’s role in overseeing compounding pharmacies.

Loading comments...
Subscriber Log In

You have reached the limit of 5 free articles in a month

Stay informed with unlimited access to Boston’s trusted news source.

  • High-quality journalism from the region’s largest newsroom
  • Convenient access across all of your devices
  • Today’s Headlines daily newsletter
  • Subscriber-only access to exclusive offers, events, contests, eBooks, and more
  • Less than 25¢ a week
Marketing image of BostonGlobe.com
Marketing image of BostonGlobe.com