President Trump Addresses Drug Pricing in State of the Union AddressBy
During his State of the Union address, President Donald Trump addressed several policy issues relating to healthcare, including lowering prescription drug costs and improving access to investigational drugs.
“One of my greatest priorities is to reduce the price of prescription drugs,” said Trump in the January 30, 2018 address. “In many other countries, these drugs cost far less than what we pay in the United States, and it’s very, very unfair. That is why I have directed my Administration to make fixing the injustice of high drug prices one of my top priorities for the year. Prices will come down substantially. Watch.”
President Trump also addressed increasing patient access to investigational drugs, the so-called “right to try.” The “right to try” refers to allowing patients with terminal illnesses more latitude to take experimental treatments by allowing them to try medicines that have passed Phase I of the FDA approval process and remain in clinical trials (Phase II or Phase III) but that have not yet been approved by the FDA. Such measures allow doctors, patients, and drug or device manufacturers to work together directly with the patient for these investigational treatments. Thirty-eight states have passed “right-to-try” laws, according to information from the National Right To Try Movement, supported by the Goldwater Institute, a Phoenix Arizona-based advocacy organization.
On the federal level, right-to-try legislation has passed one house of Congress. In August 2017, the US Senate passed the Right to Try Act of 2017, which amends the Federal Food, Drug, and Cosmetic Act to exempt, from specified requirements and restrictions the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and is unable to participate in a clinical trial involving the drugs. The Senate-passed bill prevents federal agencies from interfering with the implementation of the state-passed laws.
In the State of the Union address, Trump urged Congress to pass “right to try” legislation. “We also believe that patients with terminal conditions, terminal illness, should have access to experimental treatment immediately that could potentially save their lives,“ said Trump. “People who are terminally ill should not have to go from country to country to seek a cure. I want to give them a chance right here at home. It is time for the Congress to give these wonderful, incredible Americans the ‘right to try.’”
The President also highlighted the number of drug approvals by the US Food and Drug Administration (FDA) in 2017. “To speed access to breakthrough cures and affordable generic drugs, last year the FDA approved more new and generic drugs and medical devices than ever before in our history.”
In 2017, the FDA approved 46 new molecular entities (NMEs), more than double the number approved in 2016 and a 21-year high. Following a downturn in 2016 when only 22 NME were approved, new drug approvals in 2017 outpaced a recent high of 45 NME approvals in 2015 and was the second highest total since 1996 when 53 NMEs were approved, according to information from the FDA. In 2017, the FDA recorded the highest annual total of generic drug approvals (1,027 generic drug approvals: 843 full approvals and 184 tentative approvals) in the agency’s history, according to information from the FDA