Medical Innovation Among Key Issues for Sen. Alexander

By Jeannie Baumann

Nov. 9 — Advancing biomedical innovation and health technology issues are expected to stay in the forefront of health-care issues for a Senate health panel in the next Congress.

With Republicans retaining control of both chambers, Sen. Lamar Alexander (R-Tenn.) likely will keep his position as chairman of the Health, Education, Labor, and Pensions Committee when the next Congress convenes in January. Alexander is working with ranking member Patty Murray (D-Wash.) to lead the Senate effort to pass a counterpart to the 21st Century Cures bill (H.R. 6). Cures is a bipartisan effort to spur new medical treatments. Lawmakers in both the House and the Senate have said they want to work on the bill when the lame duck session convenes Nov. 14.

Senate Majority Leader Mitch McConnell (R-Ky.) confirmed his plans to make Cures a priority during the lame duck session at a Nov. 9 press conference. “The president’s interested in the precision medicine part of that, the vice president is interested in the cancer moonshot part of it, I’m interested in the regenerative medicine part of it,” he said. “I’d like to see us finish that important new measure this year.”

Alexander also has expressed support for a number of research-related projects, including White House initiatives to advance precision medicine and the cancer “moonshot” to try to double the rate of progress on oncology treatments and prevention therapies.

In a post-election statement, Alexander congratulated President-elect Donald J. Trump and called on him and Congress to “work together to address the voices of anger and despair, and of hope, that we heard yesterday.” “This includes reducing Washington’s role in our lives, making it easier to find a good job and less expensive health care, and making our system more fair. It’s time to put the election behind us,” he said Nov. 9.

Reforming and possibly repealing the Affordable Care Act is likely to be a top priority in both the House and the Senate, and an aide to Alexander said one of his priorities for next year will be “enacting structural reforms to provide Americans relief from the Obamacare emergency in Tennessee and other states and to ensure that more Americans can access private health insurance plans that fit their needs and their budgets.”

FDA User Fees, Lab Tests

Alexander’s priorities related to biomedical research include:

•  reauthorizing the user fee agreements between the Food and Drug Administration and the drug, device and generic drug industries, which Alexander’s office said will "[support] biomedical innovation to get safe, cutting-edge treatments and cures into doctors’ offices and patients’ medicine cabinets more quickly”; and
•  supporting the development of medical countermeasures to respond to both public health emergencies such as the Zika virus outbreak and potential biological threats.

Alexander also said he wants to tackle laboratory-developed tests, which are key to the precision medicine initiative as accurate, reliable diagnostic screening tools will determine whether a patient will respond to a specific drug. In a September hearing, he criticized the FDA’s 2014 proposal to oversee these tests as doubling up on regulation already being done by the Centers for Medicare & Medicaid Services. In the next session, Alexander will work “to ensure access to affordable, reliable lab-developed tests.”

The HELP chairman’s office also listed “improving the flow of health information so that doctors can spend more time with patients, and patients can have easier access to their health information” as a priority, “at the same time, working to help ensure patients can trust that their sensitive health information is kept private and is protected from cyber threat.”

Mental health and substance abuse disorders also will remain a priority for the committee, his office said, “including improving access to treatment for the one in five American adults who suffers from mental illness and those in Tennessee and other states suffering from substance use disorders like addiction to opioid painkillers.”

Drug Costs?

Although rising drug costs became a top issue in the campaign, particularly for Democrats, Bloomberg Intelligence senior analyst Brian Rye said Nov. 9 he expects drug pricing won’t be as high a priority in a Republican Congress and Trump administration.

Referring to Democratic presidential nominee Hillary Clinton, Rye told Bloomberg BNA, “both she and Bernie Sanders did a whole campaign to make drug pricing a priority” but it’s just not one for Republicans.

“I think it falls well below Obamacare on their list of health-care priorities,” Rye said. A Republican majority also means Sen. Bernie Sanders (I-Vt.) won’t be the chairman of the HELP committee; he had made it clear he wanted that position after dropping out of the presidential race.

“That’s an important part of this,” Rye said, adding Sanders could have held a number of hearings and investigations on drug pricing and likely could have delayed user fee negotiations. “The universe of biopharmaceutical companies is probably pleased with the environment they’re going to be dealing with for at least the next the couple years.”

Bipartisan Support for Research

Mary Woolley, president and chief executive officer of Research!America, told Bloomberg BNA research for health has consistently been a bipartisan issue. She cited recent funding increases for the National Institutes of Health and other federal health agencies and efforts to advance Cures legislation to accelerate the discovery, development and delivery of new therapies.

“Senator Roy Blunt (R-Mo.), Senator Dick Durbin (D-Ill.), Representative Nita Lowey (D-N.Y.) and Representative Tom Cole (R-Okla.) are among the congressional leaders who strongly believe that support for research is key to addressing the many health challenges afflicting Americans,” she said in a Nov. 9 statement, referring to appropriators who have led labor-health funding issues. “We look forward to working with the next Congress and the new Administration to ensure that federally-funded research and private sector medical innovation rise to the top of national priorities.”

The Trump campaign didn’t release many positions on medical research, but president-elect Trump has said he supports funding for Alzheimer’s research ( 10 LSLR, 9/16/16 ). In an October 2015 radio interview posted by the left-leaning group Media Matters with conservative host Michael Savage, Trump criticized the NIH, saying “I hear so much about the NIH, and it’s terrible.”

The American Association for Cancer Research issued a statement calling on Trump to support the cancer moonshot initiative--an effort from President Barack Obama’s administration led by Vice President Joe Biden. “Failure to capitalize upon the scientific discoveries of today is simply not an option,” AACR CEO Margaret Foti and Nancy Davidson, who is director of the University of Pittsburgh Cancer Institute and AACR‘s president, said in a joint statement. “Therefore, we call on Trump to rally all Americans around this cause of making cancer research a national priority so that we are able to continue to make the strides required to eradicate cancer worldwide.”

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

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