Last year’s meningitis outbreak linked to the New England Compounding Center, which killed dozens of people and left hundreds sick, is evidence of risks associated with producing and distributing drugs outside of Food and Drug Administration (FDA) oversight, according to the group.
Thompson, a former Republican governor of Wisconsin, said the group would push for changes designed to avert a repeat of the outbreak.
“We’re seeing too many companies mass manufacturing and distributing medications all over the country outside of FDA oversight,” said Tommy Thompson, who is chairman of TherapeuticsMD, a specialty pharmaceutical company. “We formed this group to help ensure the voices of those who support strengthening current oversight are heard.”
Sarah Sellers, a public health expert, is a co-leader of the group, which is working with patient-rights advocates, FDA approved drugmakers and other medical groups.
The working group is pressing for increased restrictions on drugs made without FDA supervision and that don’t meet federal safety standards and a ban on the compounding of drugs that are essentially copies of medication already on the market.
Also on the group’s priority list are regulations requiring that patients be told when they are getting compounded drugs that are exempt from FDA scrutiny.
Thompson said the group aims to work closely with the Senate Health, Education, Labor and Pension Committee, which is currently weighing a bill to strengthen the FDA's regulatory authority over compounding pharmacies.
Manufacturers of compounded drugs are lining up against the measure.
Former HHS chief urges crackdown on compound pharmacies
By Benjamin Goad - 06/19/13 03:11 PM EDT