The head of the Food and Drug Administration said many people are to blame for high drug prices, including the agency itself.
“I don’t know that there is one culprit,” FDA Commissioner Scott Gottlieb said Thursday. “There is probably a lot of blame to go around.”
Gottlieb spoke before an event in Washington of the Pharmaceutical Care Management Association, a group that represents drug middlemen called pharmacy benefit managers.
Gottlieb has levied criticism in recent weeks on the drug supply chain, but Thursday he touched on the agency’s own failings.
He said the FDA needs to do more to entice competition in the generic drug market.
Chief among important actions it could take is improving the drug approval pathway for generic drugs, which are cheaper versions of a brand name drug.
The generic approval pathway worked well when drugs were just one molecule.
“It doesn’t work so well in the world where more and more drugs are complex formulations,” Gottlieb said. “We haven’t laid out good scientific parameters.”
Gottlieb said the agency is moving to improve competition for complex brand name drugs, including regulatory guidance two years before a patent for a brand-name drug expires to help generic companies prepare their own version.
He also renewed his criticisms of the drug supply chain, especially efforts to forestall generic competition.
A generic company sometimes needs 2,000 copies of a brand name drug to conduct its own testing to submit an FDA application.
However, some brand name companies have withheld sending those samples, citing FDA safety regulations. The maneuver eventually sparks a lawsuit by the generic company and delays competition.
Congress is pursing the CREATES Act, which would give generic companies a quicker pathway to getting the samples.
Gottlieb also called out the pharmacy benefit managers for their role in limiting access to generic drug samples. A PBM oversees the list of approved drugs for an employer-sponsored or large group insurance plan. The PBM also often negotiates with a drug maker for rebates to products.
A brand name drug company sometimes enters into an agreement with a specialty pharmacy to distribute the product. As a part of that agreement, the specialty pharmacy agrees to not provide the generic company with samples.
“I know PBMs aren’t directly complicit in all of these, but I know they also own a lot of these specialty pharmacies,” Gottlieb said.
