With U.S. Senator Chuck Grassley

Q: What is contributing to the cost of prescription drugs?

A:  There’s no doubt that the rising cost for prescription medicine weighs heavily on the minds of Iowans. The issue comes up at nearly every one of my county meetings across the state. That’s because it hits so close to home for Iowa households: their pocketbooks and their medicine cabinets. The miracles of modern medicine have dramatically improved and extended the quality of life for people with debilitating, chronic and even life-threatening conditions. Prescription drugs and biologics require tremendous research, time and investment to bring the latest wonder drug to market. Scientists, researchers and doctors work tirelessly to develop ideas into medicines which help all of us, and innovators should be rewarded for their investments and creative efforts in advancing cures for patients all over the world.

As a federal policymaker, I want to make sure our system of free enterprise works. That means writing health care, tax, and trade policies that foster growth, competition, product safety and consumer choice. It means keeping an eye out for predatory tactics and exercising robust oversight of anti-competitive business practices that prevent the free market from firing at all cylinders. Consider the Hatch Waxman Act. It creates a streamlined process for generic drug companies to secure approval from the Food and Drug Administration (FDA) of their prescription medicines to gain entry to the marketplace as soon as a patent on a brand drug expires. Streamlining the process generates competition and lower prices for consumers as soon as possible. However, we have learned of tactics by both brand and generic drug manufacturers that frustrate the intent of the Hatch Waxman law and keep less expensive drugs off the pharmacy store shelves for longer periods of time. For example, pay-for-delay deals between brand and generic drug companies push back generic drug entry in the market and end up costing consumers and taxpayers billions of dollars.

Q:  What is the latest anti-competitive tactic that is keeping drug costs high for Iowans?

A: Once an idea for a new medicine is fully developed, it is up to the FDA to keep our medicine cabinets safe. It is crucial that the FDA makes decisions solely based upon science and not political pressure. Additionally, when the FDA develops a safety program for drugs, drug companies must follow the safety program. In fact, this was the intent of Congress when it authorized a safety program at FDA called Risk Evaluation and Mitigation Strategy (REMS). We have learned that certain brand companies are deploying strategies to delay generic competitors by exploiting these REMS safety protocols to withhold access to drug samples for bioequivalence testing and generic drug development in violation of FDA regulations and the Hatch Waxman Act.  We also have heard that certain brand companies are misusing REMS to deny access to the REMS single shared system requirements under FDA regulations. The Federal Trade Commission (FTC) shares my concerns about these anti-competitive strategies.  Manipulating the drug safety regime to delay generic drug entry in the market is wrong. I’m working to stop it.

Q:  How would your bipartisan CREATES legislation save patients and taxpayers money?

A:  The Creating and Restoring Equal Access to Equivalent Samples Act (CREATES) would address the specific anti-competitive abuse and manipulation of the FDA REMS safety regulations we have learned about from the FTC and generic companies. First, by refusing to sell samples of their product to potential generic competitors, some brand companies are unilaterally putting the brakes on the competition. The Hatch Waxman regime requires a generic manufacturer to conduct testing to certify its product is bioequivalent to the brand drug. If the generic company can’t purchase samples of the brand drug to conduct testing, competition effectively is taken off the table. Second, by denying generic companies to join a safety protocol with a brand company as required by FDA regulations, generic companies effectively are blocked from bringing their product to market. My bill would address these two barriers by giving a generic company a specific legal remedy to pursue injunctive relief in federal court. Specifically, it would allow the generic company to obtain the samples it needs or gain court-approved access to share safety protocol testing. Finally, to nip future shenanigans in the bud, my bill would authorize a judge to award limited damages. The possibility of a financial slap on the wrist has a proven deterrent effect that will encourage companies to do the right thing or risk paying the consequences.

The bottom line is simple. Keeping prescription drug prices artificially high by manipulating the safety protocol system is costing consumers and taxpayers a fortune. Using an FDA regulatory process set up as a safety measure to instead block generic competition is not fair play by the brand companies. I’ll continue working to fix flaws in our regulatory, trade and tax policies with targeted, reasonable reforms that make a difference for Iowans and their hometown hospitals. From my anti-pay-for-delay bill, the Preserve Access to Affordable Generics Act and now my CREATES bill, I’m working to provide common sense solutions that would result in less expensive drugs for Iowans.

Senator Grassley is chairman of the Senate Judiciary Committee. He recently introduced the bipartisan CREATES Act to address anti-competitive practices in the pharmaceutical industry. His bill is supported by a broad coalition, including the Iowa AARP, Iowa Medical Society, Iowa Pharmacy Association, AARP, American College of Physicians, AFL-CIO, the American Hospital Association.