President Trump on Wednesday signed into law a so-called "right-to-try" bill (S 204) and in a surprise announcement said pharmaceutical companies in the coming weeks plan to announce "voluntary" cuts to prescription drug prices.
June 11 webconference: 5 things you need to know about specialty pharmacy strategy
Trump signs 'right-to-try' bill
About 40 states currently have laws that allow patients to access experimental drugs that have not yet been approved by FDA. The right-to-try bill Trump signed Wednesday establishes federal rules to expand such access to patients in all 50 states who have "a life-threatening disease or condition" and have "exhausted approved treatment options and [are] unable to participate in a clinical trial."
The new law allows such patients to request experimental treatments directly from drugmakers, and requires patients to provide informed consent in writing before obtaining the treatments. Drugmakers are not required to provide patients with the requested treatments. Those that choose to do so are required to provide the federal government with an annual summary of the drugs' uses, including "any known serious adverse events" that occur.
The new law protects drugmakers and physicians who help patients get experimental drugs from potential legal repercussions. Health care providers are protected under the law as long as they do not engage in "reckless or willful misconduct" or "gross negligence," or harm a patient intentionally.
During a signing ceremony for the bill, Trump said, "For countless patients, time is not what they have." He added, "With the right to try, patients with life-threatening illnesses will finally have access to experimental treatments that could improve or even cure their conditions."
Separately, FDA Commissioner Scott Gottlieb in a statement said the agency "stands ready to implement" the right-to-try law "in a way that achieves Congress' intent to promote access and protect patients."
Trump says drugmakers plan to announce 'voluntary' price cuts
In addition, Trump during the signing ceremony unexpectedly said some "big drug companies in two weeks said they're going to announce … voluntary massive drops in prices" because of the Trump administration's recent proposals targeting prescription drug prices.
Trump did not provide details on which companies intend to announce price cuts, or how they are planning to implement the cuts, Reuters reports. Industry officials and lobbyists said they were not aware of any such forthcoming announcements, and an HHS spokesperson said the department had nothing to add to Trump's comments, according to Reuters.
Trump during the ceremony also said his administration in the coming weeks would make an announcement on "health care." In comments directed toward HHS Secretary Alex Azar, Trump said, "We're going to have another exciting news conference over the next, what, three weeks? Four weeks? Two weeks? What do you think? On health care. We're going to have great health care."
According to CQ News, Trump said his administration is planning to release "two plans," and specifically mentioned his administration's proposal regarding association health plans. The other plan to which Trump referred likely relates to his administration's proposal on short-term health plans, Axios' "Vitals" reports (Hellmann , The Hill, 5/30; Hellmann , The Hill, 5/30; Fritze, USA Today, 5/30; McIntire, CQ News, 5/30 [subscription required]; FDA release, 5/30; Baker, "Vitals," Axios, 5/31; Abutaleb/Holland, Reuters, 5/30).
Next: 5 things your organization must do to manage care around high-cost drugs
Join us on Monday, June 11 at 1 pm ET to learn how the specialty pharmacy landscape is changing and what health systems must do to manage care around these high-cost drugs.