FDA Reform Focus of Senate's 2nd Cures Markup

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By Jeannie Baumann

Feb. 26 — A Senate health committee is expected to focus on bipartisan FDA reform efforts during an upcoming markup session that's part of a larger initiative to accelerate the development of new medical treatments.

The Senate Health, Education, Labor and Pensions Committee has scheduled the markup session for March 9 as lawmakers continue to battle over whether to include mandatory funding for medical research in the legislation. The Senate initiative would modernize the Food and Drug Administration and the National Institutes of Health, among other agencies, as part of a companion effort to the House-passed 21st Century Cures bill (H.R. 6).

The HELP committee already held the first of three planned medical innovation markup sessions in February, during which it approved legislation to reform health information technology regulations along with six other bills. The February package included three research-related bills .

“Even though it’s a piecemeal approach, it’s conceptually pretty similar to the 21st Century Cures that the House passed back in July,” Brian Rye, a health-care policy analyst for Bloomberg Intelligence, said Feb. 18.

HELP Chairman Sen. Lamar Alexander (R-Tenn.) said during a separate hearing on the Zika virus that he expects the committee to approve a total of 45 to 50 measures by the first week of April during the three markup sessions. The final session is planned for April but hasn't been scheduled yet.

Breakthrough Devices, Other Bills

The bills on the docket for the March markup include:

  • The Advancing Hope Act of 2015 (S. 1878), which would expand the priority review voucher program for rare pediatric diseases to include treatments for sickle cell disease and pediatric cancers and remove a provision terminating the program.
  • The Medical Countermeasure Innovation Act of 2015 (S. 2055), designed to spur the development of drugs, devices and preventative treatments to protect people in the event of a global pandemic or biological weapon attack by establishing, among other incentives, another priority voucher program for developers of medical countermeasure products. It would also change language in the Public Health Service Act (42 U.S.C. 247d–6b(c)) to require, rather than recommend, a special reserve fund to develop these countermeasures.
  • The Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act (S. 1101), which would exclude from medical device regulations certain types of software commonly used to run a medical practice—such as software for financial records or for clinical laboratory testing that doesn't analyze test data.
  • The Combination Products Innovation Act of 2015 (S. 1767), which would allow the FDA to rely on prior findings of safety and efficacy when deciding whether to approve a combination product. The measure also would make it easier for the FDA to address whether a product is reviewed as a drug, device or biologic based on the product's primary intended purpose ;
  • The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S. 1077), which would create a program to expedite review of so-called breakthrough devices, similar to an existing program for drugs.
  • The Adding Zika Virus to the FDA Priority Review Voucher Program Act (S. 2512), which would add Zika to the list of eligible diseases for the FDA priority review voucher program.

    A statement from the HELP committee said that additional bipartisan proposals may be added at a later date.

    Precision Medicine, Cancer Moonshot

    During a Feb. 24 hearing on the Zika virus, Alexander said the committee also will consider measures to support the White House efforts in precision medicine, along with “some support for cancer moonshot and other funding for NIH.” The moonshot refers to an ambitious effort to accelerate innovation in cancer treatment and prevention.

    Amy M. Miller, executive vice president of the Personalized Medicine Coalition, told Bloomberg BNA that while “we cannot rule out the possibility that the HELP Committee might propose its own set of initiatives in support of personalized medicine,” it's more likely that the committee will introduce a bill that supports the White House Precision Medicine Initiative and the Cancer Moonshot Task Force that are already underway.

    “The Senate HELP Committee’s attention to biomedical innovation represents an opportunity for Congress to authorize funding that would accelerate the Precision Medicine Initiative’s progress,” Miller said in an e-mail. “PMC has supported the PMI since the President announced it during his State of the Union Address in January of 2015. This project could improve and extend the lives of many patients while concurrently transforming how all of us experience health care.”

    Jeff Allen, executive director of the Friends of Cancer Research, told Bloomberg BNA that it remains to be seen if the Senate HELP panel is able to reach consensus on more bills, or if this is the full docket of items members will consider in March.

    “It’s a traditional activity of the HELP committee to try and only move forward at the markup things that have broad bipartisan support, and I think they want to keep that tradition intact here,” Allen said, adding his understanding is that the Senate committee has been discussing a number of items that are in the 21st Century Cures bill.

    “The Senate wanted to take their own approach to this rather than just blindly accept whatever the House passed through,” he said. “So they’ve been having careful deliberations about some of the same topics. I think it just remains to be seen whether they can get agreement with the different approaches that they might be considering in those areas.”

    Mandatory Funding

    Since the House passed the 21st Century Cures bill in July, several issues have emerged, Rye observed, including disagreement on whether the Senate legislation should include mandatory funding as did the House. Alexander said during the Zika hearing that he wants the funding mechanism to undergo a separate legislative process—to be worked out on the Senate floor—that leads to a bipartisan funding agreement.

    “There is not bipartisan agreement in the committee right now, but I think we can get there when we go to the floor,” Alexander said during the Zika hearing. “We can't work that out in committee, but we can work it out on the floor” and then present both pieces of legislation to Senate Majority Leader Mitch McConnell (R-Ky.).

    Rye noted that Senate HELP Democrats—particularly Sen. Elizabeth Warren (D-Mass.)—have been particularly adamant about the need for mandatory funding.

    “I don’t know what that’s going to look like,” Rye said, but “that seems to be something that the Democrats especially care about.”

    Indeed, during the February markup, Warren said that until the committee can reach bipartisan agreement on a package to strengthen the FDA and fund that NIH, she will not support “any more so-called innovation legislation” as a member of HELP.

    “Because big medical breakthroughs don’t come from tweaking the process over at FDA. Big medical breakthroughs come from increasing basic research. And that’s where we’re falling dangerously behind,” Warren said. “Sure, heading into an election year, it would be easier to pass some small bills, call it medical innovation, declare victory, and quit. We cannot punt this to some vague promise to add funding later on. This committee can and must include mandatory funding in any innovations bill. I’m tired of pretending.”

    Sen. Patty Murray (D-Wash.), the top Democrat on HELP, also reiterated her support for mandatory funding to advance medical technologies. “We cannot realize that goal without sustained investments in innovative medical research and efforts to ensure patient and consumer safety,” she said during the February markup. “So I’ve made clear, the path to a bipartisan deal on medical innovation must include mandatory investments in the NIH and the FDA and must uphold the gold standard of FDA approval.”

    Allen of Friends of Cancer Research said under current budget constraints, the traditional paradigm of the authorizing committees proposing different programs and the appropriations committees determining how to fund them has drifted into unique budgeting models involving mandatory funding.

    “That starts to make some people uneasy when you start to go around some of these historic processes a little bit,” Allen said. “What you saw in the House was when they finally got to the point of identifying potential funding sources, the bottleneck opened up and other issues started to be able to be sorted out relatively quickly. Perhaps we could see the same thing occur in the Senate.”

    At the same time, Allen said, “when proposing all of these programs, we do want to be very careful about potential unfunded mandates and I think the Congress is very sensitive to that.”

    Drug Pricing

    Rye noted that since the House passed its H.R. 6, there's been a huge focus on drug pricing, especially after Democratic presidential candidate Hillary Clinton vowed in September to reform the drug industry and sent biotech sector stock values plummeting .

    “Democrats both on the campaign trail and in Congress have made drug pricing an issue and are painting the pharmaceutical and biotech industry in a not-so-positive light,” Rye told Bloomberg BNA. “You wonder how excited they are about enacting or going forward with legislation that has several provisions in it that are deemed to be favorable to the industry that they are simultaneously trying to paint as a villain.”

    Finally, Rye questioned whether the medical innovation legislation could be enacted this year.

    “Congress often does its best work when we have a deadline. But there’s no deadline here. I think there’s some support for the bill, but they don’t have to do this,” Rye said. “Senator Alexander has made this a priority and wants to move forward with this. But there are some potential stumbling blocks and because it’s not must-pass legislation, it’s certainly not a slam dunk.”

    Allen said he hopes the House's 21st Century Cures bill, the Senate's medical innovation agenda and the White House's cancer moonshot and precision medicine initiatives “can converge and result in some meaningful programs that can get broad support and be rapidly implemented.”

    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