President Trump Announces Plan on Drug PricesBy
In a speech delivered on May 11, 2018, President Donald Trump highlighted his plan for addressing drug pricing in the US, including speeding up the approval process for over-the-counter products, requiring price disclosures in commercials, and addressing patent protection.
In his speech, he noted multiple ways his Administration plans to address drug pricing by increasing drug competition. “We are getting tough on the drug makers that exploit our patent laws to choke out competition. Our patent system will reward innovation, but it will not be used as a shield to protect unfair monopolies,” he said. “The FDA [US Food and Drug Administration] will also speed up the approval process for over-the-counter medicines so that patients can get more medicines without prescription. Finally, as we demand fairness for American patients at home, we will also demand fairness overseas. When foreign governments extort unreasonably low prices from US drug makers, Americans have to pay more to subsidize the enormous cost of research and development. In some cases, medicine that costs a few dollars in a foreign country costs hundreds of dollars in America for the same pill, with the same ingredients, in the same package, made in the same plant. And that is unacceptable. You can look at some of the countries; their medicine is a tiny fraction of what the medicine costs in the USA. It’s unfair and it’s ridiculous, and it’s not going to happen any longer.”
President Trump also discussed banning the so-called “pharmacist gag rule,” which allows health insurance companies and pharmacy benefits managers to use their contracts to prevent pharmacists from telling their customers about less expensive ways to buy prescription drugs. He also discussed giving Medicare Part D plans new tools to negotiate lower prices for more drugs and making sure that Medicare Part D incentives encourage drug companies to keep prices low.
Following President Trump, US Department of Health and Human Services (HHS) Secretary Alex Azar briefly spoke. Azar added that HHS will look into guiding the US Food and Drug Administration (FDA) to enact a rule that requires the price of medicines to be disclosed in drug commercials.
In response to President Trump’s speech, FDA Commissioner Scott Gottlieb commented on what steps the FDA is taking that are in line with President Trump’s plan. “The FDA shares the goal of ensuring that American patients have access to quality and affordable care that meets their needs,” Gottlieb said in a May 11, 2018 agency statement. “This is why we’re prioritizing actions to encourage the timely development and approval of generics and biosimilars. To date, we’ve taken a number of steps as part of our Drug Competition Action Plan (DCAP). We’re helping remove barriers to generic-drug development and market entry in an effort to spur competition that results in lower drug prices for patients, and greater access.” Gottlieb also said the agency is committed to reducing the cycles of review that generic applications typically undergo, calling out abuses of the system that impede competition and taking steps to support complex generic-drug development and application review.
Industry trade associations respond
Pharmaceutical trade associations, including the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization (BIO), and the Association for Accessible Medicines (AAM), also commented on President Trump’s announced intentions.
Stephen J. Ubl, PhRMA President and Chief Executive Officer (CEO), issued a statement on President Trump’s drug pricing blueprint with particular concern about the changes in Medicare Part D. “These far-reaching proposals could fundamentally change how patients access medicines and realign incentives across the entire prescription drug supply chain,” Ubl said in a May 11, 2018 statement. “The proposed changes to Medicare Part D could undermine the existing structure of the program that has successfully held down costs and provided seniors with access to comprehensive prescription drug coverage. We also must avoid changes to Medicare Part B that could raise costs for seniors and limit their access to lifesaving treatments.”
BIO President and CEO Jim Greenwood also raised concerns in response to President Trump’s speech. “We look forward to working with the administration on solutions that help provide all patients access to prescription drugs with out-of-pocket costs they can afford,” Greenwood said in a May 11, 2018 statement. “However, we have concerns that some of the ideas proposed today could, if adopted, hurt patient access to the medicines they need today and the future cures and treatments they’re desperately waiting for America’s biopharmaceutical innovators to discover.”
President and CEO of AAM, Chester Davis, Jr., commented favorably on the speech, agreeing with President Trump’s premise of generating competition. “President Trump’s embrace of generic and biosimilar competition as a key to lowering brand-name drug prices is an important step forward for patients coping with skyrocketing health care costs,” said Davis. “Patients will benefit most from meaningful initiatives that ensure robust competition and timely access to these life-saving medicines.”