Proposal Looks To Give FDA Tighter Control On Compounding Facilities
Lawrence LeBlond for redOrbit.com – Your Universe Online
Nearly seven months after reports of the first deaths from a dangerous meningitis outbreak made headlines, the US Food and Drug Administration (FDA) may now get greater control on pharmacies that compound sterile drugs.
A legislative proposal was outlined on Friday in response to the outbreak that has so far killed 53 people and sickened hundreds more. The outbreak was linked to a contaminated steroidal injection produced and distributed by Massachusetts-based New England Compounding Center (NECC).
According to Reuters´ correspondent Tony Clarke, the proposal looks to present a clearer distinction between compounding pharmacies which tailor drugs for individual patients and those which make and ship products across the country giving physicians easier access.
Though Republicans in Congress have been adamant over the fact the FDA was not aggressive enough in its oversight of NECC, the agency maintains it did not have the legal authority to step in. The FDA did concede more oversight was needed, however.
Under the proposed legislation, a new class of drug companies would be created, known as “compounding manufacturers.” Companies under this title would be regulated by the FDA but still be exempt from the all the regulatory requirements that pharmaceuticals adhere to.
While companies under this heading would be required to provide the FDA with certain information, they would not need to submit their products for approval before distribution, or enter into complicated negotiations with the agency about what should be included in package inserts.
With more than 2,800 compounding pharmacies in business in the US, it would be difficult to say just how many would fall under the new “compounding manufacturers” title, but initial estimates put that number at less than 500, according to Clarke.
Such companies would not be defined by sales volume, but by distribution area (those which ship across state lines) and the potential for contamination risks.
Under the new heading, these companies would be required to register with the FDA, but would no longer be licensed as pharmacies. The firms would also be required to report any and all problems reported by physicians and/or their patients.
All compounding facilities that do not fall under the new title would continue to be licensed and regulated by state pharmacy boards.