Republican lawmakers released a draft of a new bill that aims to stem drug shortages after Republicans in the House Energy and Commerce Committee blocked efforts by their Democratic colleagues to tackle drug shortages in the reauthorization of a key pandemic preparedness bill.
The draft bill, called the Stop Drug Shortages Act, would attempt to correct some of the mismatched financial incentives that contribute to drug shortages. It would also increase disclosure requirements for generic drug sponsors, give more authority to the FDA and offer an additional exclusivity incentive for companies that carry out
shelf-life extension studies.
Energy and Commerce Committee Republicans plan to accept feedback on the discussion draft through Aug. 25 and then plan to introduce the legislation as a standalone bill, a GOP House Energy and Commerce aide told Endpoints News .
“America is the leader in developing innovative treatments and cures,” Rep. Cathy McMorris Rodgers (R-WA) said in a release on Friday. “Yet the economics of our convoluted health care system create shortages — particularly of low-cost and generic drugs — that harm patients in need.”
Lawmakers on the Senate side are also making some progress with their own drug shortage legislation. A bipartisan group of senators on Thursday introduced legislation that aims to bring generics manufacturing to US soil, and the Senate Health Committee earlier this month advanced its version of the Pandemic and All-Hazards Preparedness Act that includes added authority for FDA to remedy shortages.
FDA
The draft bill would require generic drug application holders to disclose information related to the active pharmaceutical ingredient manufacturers for which they source more than 60% of their API supply. It would also require sponsors to report to FDA each year on how much API is used in manufacturing a product.
The legislation would also allow 503B compounding pharmacies to compound a drug within 30 days of it showing up on FDA’s drug shortage database, and it would allow those facilities to dispense a compounded drug within 180 days of it showing up in the shortage database.
The bill also would require FDA to establish a pilot program to conduct pre-approval inspections for new domestic manufacturing facilities to speed up the licensing process for generics made in the US.
340B drug discount program
The bill would exempt the makers of generic, sterile injectables approved to treat at least one serious disease or condition from having to provide 340B rebates if there is more than one company making that product.
It would also direct the Government Accountability Office to carry out a study on the number of generics subject to 340B penny pricing, or that cost $1 or less, and evaluate the number of those drugs that have been in shortage over the last 10 years.
Medicaid
The bill would set a rebate cap for certain drugs under Medicaid, including barring additional inflationary rebates for generic sterile injectables that have at least one indication for a serious disease or condition made by more than one manufacturer. It would also suspend additional inflationary rebates for drugs, either in short supply or at risk of shortage.
It would also prohibit rebates for generics either in shortage or at risk of shortage from being higher than double its average manufacturer price.
Medicare
The bill would require the CMS to phase out the rebate reduction or waiver for drugs that are exiting a shortage. It would also require the agency to conduct a study on market-based pricing for Medicare Part B drugs in shortage.
drug shortages
