Daily on Healthcare: Ted Cruz bill would speed FDA approval of drugs OK’d in other countries

By | July 19, 2019

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TED CRUZ BILL WOULD SPEED FDA APPROVAL OF DRUGS OK’D IN OTHER COUNTRIES: Drugs and medical devices that have been authorized in other developed countries would face fast-track approval in the U.S. under a bill introduced Thursday by Ted Cruz.

The bill, the “RESULTS Act,” would give the Food and Drug Administration 30 days after a company sends in an application to decide whether it wants to greenlight a drug, device, or biologic approved in another country that adequately checks for safety and effectiveness. If the FDA decides to reject the application, Congress would have the power to override the decision.

At this time, the only co-sponsors are other Republicans: Ron Johnson of Wisconsin and Mike Lee of Utah.

The bill is likely to face similar concerns that are raised when the topic of drug importation comes up. Also, public health advocates have raised safety concerns over drugs and medical devices that have been approved too quickly, because they’re tested in a limited population. Drugs sometimes come with further warnings or even get pulled from the market after they have been tried by more people, showing side effects that weren’t apparent during clinical trials.

But conservatives worry that life-saving drugs aren’t getting to patients fast enough. Cruz’s goal is not only to make treatments more available but to reduce the prices of drugs and devices by introducing more competition into the market.

A significant amount of medical products first get approved in the U.S., so the legislation wouldn’t apply to a massive number of drugs and medical devices, but it could move along a more limited number of products. The bill is primarily aimed at smaller companies, which have a harder time than larger manufacturers navigating and paying for the FDA approval process.

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Good morning and welcome to the Washington Examiner’s Daily on Healthcare! This newsletter is written by senior healthcare reporter Kimberly Leonard (@LeonardKL) and healthcare reporter Cassidy Morrison (@CassMorrison94). You can reach us with tips, calendar items, or suggestions at dailyonhealthcare@washingtonexaminer.com. If someone forwarded you this email and you’d like to receive it regularly, you can subscribe here.

GOP SENATORS PUSH AGAINST ABORTION MEASURES IN SPENDING DEAL: Republican senators sent a letter to President Trump Thursday to back up the White House’s pledge earlier this year to veto any spending bills that try to undo the administration’s anti-abortion measures. The letter was led by Steve Daines of Montana, founder of the Senate Pro-Life Caucus.

The House already passed a spending bill that maintains a ban on federal funding for most abortions, known as the Hyde Amendment, but Republicans will oppose some of its other provisions. For instance, the spending package would undo the Title X rule blocking doctors who receive federal family planning from directly referring for abortions. “We will strongly oppose each of these anti-life poison pill riders and will work to ensure they are not inserted into any appropriations bill before the Senate, either in committee or on the floor,” the senators wrote.

VOTE ON THE 9/11 VICTIM FUND TO COME NEXT WEEK: The Senate will vote to replenish the 9/11 Victim Compensation Fund through 2090 next week, following ardent lobbying from first responders and comedian Jon Stewart. The bill would cost $ 10.2 billion over a decade, adding to the federal deficit. Republican Senator Rand Paul of Kentucky took issue with the price tag this week, and said he will propose an amendment to require offsets.

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BIDEN USES OBAMA’S 2009 RHETORIC TO DEFEND HIS HEALTHCARE PLAN: Joe Biden channeled the rhetoric of 2009 Barack Obama Thursday in making the case for his healthcare plan, which looks similar to the Affordable Care Act but expands on its provisions. “Under the proposal I have, you would be able to keep your insurance with your employer if your employer is still prepared to pay for the insurance,” he said. Biden’s proposal would allow people to buy into a government option that would be similar to Medicare.

His remarks echoed Obama’s infamous comments in the lead-up to the passage of the ACA, later judged to be untrue, in which he promised: “If you like the plan you have, you can keep it. If you like the doctor you have, you can keep your doctor, too.”

Biden is trying to differentiate his plan from that of fellow presidential hopeful Bernie Sanders’ Medicare for All plan, which would abolish all private insurance, while saying he still supports provisions in the Affordable Care Act.

Harris also takes a page from Obama’s book: Presidential candidate Kamala Harris, a supporter of Sanders’ Medicare for All plan, echoed Obama’s statement on Jimmy Kimmel Live late Wednesday, saying: “Ninety-one percent of the doctors in America are in Medicare… the vast majority of doctors will be in that [Medicare] system, and you can keep your doctor under that system.”

HRSA AWARDS $ 20 MILLION TO BUILD HEALTHCARE WORKFORCE IN RURAL AMERICA: The Health Resources and Services Administration awarded $ 20 million to 21 different states Thursday to create more graduate medical education programs in rural areas. In an effort to train healthcare workers where health services are less accessible, Health and Human Services will work with HRSA to allocate up to $ 750,000 over three years to each of the 21 states. The goal is to retain providers in rural areas that lack access to healthcare services.

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ILLINOIS WILL REJECT OVER $ 2 MILLION IN TITLE X FUNDS IN RESPONSE TO TRUMP TITLE X RULE: Illinois Governor J.B. Pritzker, a Democrat, said Thursday the state will reject $ 2.4 million in Title X grants following the Trump administration’s announcement that clinics that directly refer patients to abortions will be barred from the funding. HHS announced Tuesday the rule will be enforced immediately. If the rule, which abortion-rights groups call a “gag rule,” were to remain in place through the end of the fiscal year, the Illinois Department of Health would provide the same sum of money to the 28 clinics that had previously received grants throught Title X.

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MONDAY | July 22

July 22-23. Better Medicare Alliance Medicare Advantage Summit. Details.

TUESDAY | July 23

11 a.m. Philbrick v. Azar oral arguments in the U.S. District Court for the District of Columbia. The lawsuit challenges Medicaid work requirements in New Hampshire.

Noon. Longworth 1310. American Action Forum on “Arbitration and Drug Pricing.” Details.

THURSDAY | July 25

8 a.m. 1777 F St. NW. The Hill event on “Policy Prescriptions: Lowering Drug Prices.” Details.

10 a.m. 1225 I St. NW. Bipartisan Policy Center event on “Improving Care for Individuals with Complex Needs.” Details.