Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Wednesday, June 19, 2013
Former HHS chief urges crackdown on compound pharmacies By Ben Goad - 06/19/13 11:11 AM ET
Former Health and Human Services Secretary Tommy Thompson on Wednesday announced the formation of a working group to press for greater oversight of compounding pharmacies.
The Working Group on Pharmaceutical Safety comes amid growing scrutiny of state-regulated compounding manufacturers who tailor drugs’ dosages or other properties to fit specific patient needs.
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.