U.S. Rep. Buddy Carter (R-GA) on Jan. 31 introduced bipartisan legislation that would strengthen competition in the generic drug market to keep consumer drug prices low.
Rep. Carter is the original cosponsor of the Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act, H.R. 938, sponsored Thursday by U.S. Rep. Kurt Schrader (D-OR).
“I am happy to introduce this bill today with my friend Representative Schrader because it will work to bring more generic competition into the marketplace faster,” Rep. Carter said. “More competition will help make these drugs more affordable and accessible for patients.”
Currently, federal law awards 180 days of market exclusivity to a drug manufacturer that’s the first to file a generic drug application with the U.S. Food and Drug Administration (FDA) for a drug that doesn’t yet have a generic, according to information provided by Rep. Carter’s office.
The 180-day exclusivity clock starts as soon as a manufacturer begins marketing the drug. At that point, all other generic competitors are blocked from coming to market, according to the congressman’s statement.
Some manufacturers have been allowed to “park” their 180-day exclusivity application before actually receiving final approval on it, subsequently blocking competition beyond the permitted 180 days, according to Rep. Carter. In such cases, other generics can’t come to the market until that final approval is given, the manufacturer begins marketing the generic drug, and the permitted 180 days have elapsed, he said.
H.R. 938 would end such first generic drug parking, Carter said.
“As the only pharmacist in Congress, one of my top priorities is making prescription drugs more affordable and accessible,” said Rep. Carter. “This proposal has support from President Trump and bipartisan members of Congress. I hope it will move through Congress as soon as possible for the benefit of all patients.”
In fact, H.R. 938 is similar to a proposal included in the Trump administration’s fiscal year 2019 budget proposal.
According to a 2019 White House budget fact sheet called, “Lower the Cost of Drugs by Reforming Payments,” the White House aims to “speed development of more affordable generics to spur competition,” by ending the anticompetitive behavior of so-called ‘parking’ of an application with the FDA that prevents additional generic manufacturers from entering the market.
The budget proposes “to ensure that first-to-file generic applicants who have been awarded a 180-day exclusivity period do not unreasonably and indefinitely block subsequent generics from entering the market beyond the exclusivity period,” according to the document, which noted that the FDA has determined that having a second generic drug on the market significantly reduces the prices of average generics by almost half the cost of a brand-name drug.
“Too many patients across this country feel a severe impact from rising drug prices, often on prescriptions they’ve been filling for years,” said Rep. Schrader. “I have long said there is not one silver bullet solution to this crisis, however, we do know that increasing competition on the drug marketplaces a check on manufacturers and keeps costs down.”
H.R. 938 has been referred for consideration to the U.S. House Energy and Commerce Committee.