U.S. Sen. Marco Rubio, R-Fla., is doubling down on his support of U.S. Sen. Jeanne Shaheen’s, D-NH, “Ensuring Timely Access to Generics Act.”
The bill “would tackle exorbitant prescription costs by increasing competition for generic drugs through better oversight of the Food and Drug Administration’s (FDA) citizen petition process.”
Shaheen first introduced the bill in 2021 and brought it back in March.
“This legislation ensures the FDA’s ability to reject citizen petitions if they believe that the primary purpose of the petition is to delay the approval of an application, thereby increasing competition in the marketplace and lowering costs for patients. The bill would also set a time limit to ensure that citizen petitions are submitted in a timely manner after the petitioning party becomes aware of the information upon which their petition is based. This time limit helps avoid instances where brand-name drug manufacturers slow down the FDA review process by filing citizen petitions shortly before a generic drug is set to be reviewed by FDA,” Rubio’s office noted when the bill was first introduced “The legislation takes the additional step of requiring the Secretary of Health and Human Services (HHS) to establish procedures for referring a petitioner to the Federal Trade Commission (FTC) if they have reason to believe a petition was submitted with the primary purposes of delaying the approval of another application.”
Other backers include U.S. Sens. Tammy Baldwin, D-Wisc., Michael Bennet, D-Col., Mike Braun, R-Ind., and Susan Collins, R-Maine.
“The COVID-19 pandemic further exposed the need to improve access to life-saving medications, which help many at-risk Americans stay healthy during this precarious time. Now more than ever, cost should never be a barrier to medical care, including medication,” Shaheen said when she introduced the proposal. “I’m glad to lead this bipartisan effort to help ease the financial strain felt by so many families by bringing more generic drugs to the market, increasing competition and driving down costs. Health care is one of the top issues I hear from Granite Staters, and I’ll continue partnering with Senators across the aisle on common-sense ways to put quality health care within reach for our families.”
“The rising cost of prescription drugs is a problem facing countless American families. Unfortunately, bad actors have been employing anti-competitive tactics to exploit the regulatory process for their own gain,” Rubio said. “Like any other industry, the pharmaceutical market needs competition to keep drug prices fair. This legislation would lower costs by preventing brand-name drug companies from abusing the FDA pharmaceutical approval process to delay generic drugs from entering the market.”
The bill was sent to the U.S. Senate Health, Education, Labor and Pensions Committee. So far, there is no companion measure over in the U.S. House.
Rubio went to bat for the bill this week in a piece that ran in the Washington Times.
“Last fall, parents lived in fear as common antibiotics like amoxicillin went out of stock. Now, our nation is experiencing another dangerous supply chain shortage…. Medication for breast cancer and leukemia, adenosine used to treat heart disease, and critical antibiotics are all in short supply,” Rubio wrote. “The core problem is a familiar one: our leaders spent decades encouraging industry to consolidate and offshore…. Today, about 70 percent of generic drug production and about 90 percent of generic active pharmaceutical ingredient (API) production takes place overseas. The vast majority of that production is traceable to China. Meanwhile, widespread consolidation and integration of pharmaceutical intermediaries, like wholesalers and group purchasing organizations, has enabled just a few actors to dictate drug prices. Together, these factors have hollowed out what should be one of our strongest industries….
“[In addition, my prediction] that the drug price controls enacted by the Inflation Reduction Act would ‘remove the incentive to produce innovative therapeutics for patients in dire need’ [was accurate]. Unfortunately, not only did innovation slow, but the law prompted ‘a ‘race to the bottom’ in price’ that made ‘expanding production…not economically viable,’” Rubio added. “There is still time to get things right, though. We can start by passing the bipartisan Ensuring Timely Access to Generics Act. We can…pass my legislation, which would encourage companies that currently produce medical and pharmaceutical equipment abroad to relocate to the U.S. And we can repeal the Inflation Reduction Act’s deadly price controls.”
