WASHINGTON – Senate Judiciary Committee Chairman Chuck Grassley is calling on Food and Drug Administration (FDA) Commissioner Scott Gottlieb to examine legislative proposals and collaborate with other government agencies to increase consumer access to affordable prescription medications.
In a letter to Gottlieb, Grassley agreed with the commissioner on the need to address abuses in the system in order to improve prescription drug costs for consumers. Gottlieb previously testified that the FDA would work to curtail gaming of FDA regulations by drug makers, improve the approval process for generic drugs and eliminate the FDA’s backlog of applications for generics.
Grassley encouraged Gottlieb to review two bills that he has cosponsored to address anti-competitive behavior by drug makers and enhance market access to less costly generic medications. The Preserve Access to Affordable Generics Act, which Grassley introduced with Senator Amy Klobuchar (D-Minn.), would expedite consumers’ access to generic drugs by cracking down on anti-competitive deals where brand-name drug manufacturers pay generic drug companies to keep cheaper generic alternatives off the market. Pay-for-delay tactics cost Americans an estimated $3.5 billion annually. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which Grassley introduced with Senator Patrick Leahy (D-Vt.), would address abuses in the Risk Evaluation and Mitigation Strategies (REMS) program by deterring pharmaceutical companies from denying samples to generic companies for product testing and by giving the FDA more flexibility in making REMS distribution systems.
Abuses to REMS programs block $5.4 billion in generic competition each year.
Grassley called on Gottlieb to consider these two bills as he works to develop a strategy at the FDA to improve accessibility and affordability of prescription drugs. Grassley also encouraged Gottlieb to work closely with the Justice Department and Federal Trade Commission to address anti-competitive behavior in the pharmaceutical industry. Both agencies play a critical role in holding companies accountable for abusing regulations and engaging in anti-competitive practices that harm consumers.
Full text of the letter
