GOP governors call on Congress to take more action on US drug shortages

 After FDA Commissioner Robert Califf, M.D., recently made comments about the untenable nature of generic drug production in the U.S., a clutch of governors has raised its own set of concerns about shortages.

This week, 11 Republican governors sent a letter (PDF) to Congress demanding action on the spate of drug shortages plaguing the U.S.

Citing shortfalls of critical meds like albuterol, amoxicillin and certain chemotherapies, the governors noted that shortages have sometimes lasted for years, often with “no good explanation for why.”

One possible reason for the shortages, they added, is tied to the fact that more than 80% of active ingredients in prescription drugs sold in the U.S. come from overseas.

“This limited supply chain creates a national security risk and leaves America competing with other nations for essential resources,” the joint letter states.

The governors called on Congress to adopt a clutch of new policy solutions to ensure adequate supplies of medicines.

Their letter calls for added transparency in the pharmaceutical manufacturing chain, ranging from the sourcing of raw materials to the finished product, including country of origin labeling. Additionally, Congress should help foster increased diversity in generic drug manufacturing with regards to both raw materials and final manufacturing, the governors said.

The group is also pressing for more transparency from the FDA about ongoing shortages and events that can cause supply chain disruptions. They further want the agency to reconsider its expiration date guidance on certain medications.

“The FDA and medical companies are currently restricted by federal law regarding their transparency policies,” the governors wrote. “Congress must grant additional authorities that allow more transparency throughout the drug manufacturing process.”

The governors also appear to favor drug importation. The group requests that Congress enable waivers to allow the purchase of medications from Canada to quickly expand the U.S. supply chain.

Lastly, the governors want the U.S. to foster a regulatory environment that is “more favorable” to domestic production.

The governors’ concerns echo those raised by Califf last week.

Discussing drug shortages during a presentation of the Alliance for a Stronger FDA, Califf said the “fundamental problem” is that “we essentially have two drug industries in the U.S.”

There’s the “innovator industry,” where Califf said he thinks "the prices are too high,” and then there’s the generics industry, where “a lot of the prices are too low.” 

“What I mean by that is that the price has been driven down below the cost of manufacturing and distributing the drug,” he said. “And we have an industry which is continuing to leave the U.S. because it’s not viable to run the business.”

The FDA currently lists around 137 unresolved drug shortages on its online database. 

https://www.fiercepharma.com/pharma/republican-governors-call-congress-resolve-spate-us-drug-shortages