BNA’s Health Care Daily Report™ sets the standard for reliable, high-intensity coverage of breaking health care news, covering all major legal, policy, industry, and consumer developments in a...
April 6 — A Senate committee approved five medical innovation bills April 6 during the final markup of companion legislation to the House's 21st Century Cures bill.
The five bills—which include language to deter the FDA from relying too heavily on guidance documents and to address privacy protection for research participants' genetic data—are the last bills the Senate Health, Education, Labor and Pensions Committee will mark up in an effort to accelerate the development of new drugs and devices. The committee has now approved a total of 19 bills with 50 proposals over three markup sessions as part of the legislative package.
However, HELP Committee Chairman Lamar Alexander (R-Tenn.) said the Senate still has more work to do, most notably reaching a bipartisan agreement on mandatory funding for the National Institutes of Health.
“The House has done its job. We’ve done most of ours,” Alexander said, reiterating statements that the medical innovation effort is the most important legislation that can move through Congress this year. “It has the promise of improving the health of virtually every American. We should make certain we finish this, and the sooner the better.”
The House approved its cures measure, H.R. 6, in 2015.
Senate Majority Leader Mitch McConnell (R-Ky.) has agreed to hold a floor vote on 21st Century Cures once the HELP committee has completed its work, Alexander said.
The committee has made progress on the issue of mandatory NIH funding, Alexander said, adding that the House's bill would provide $8.75 billion in mandatory funding for both the NIH and the Food and Drug Administration.
HELP Democrats, particularly Sens. Elizabeth Warren (Mass.) and ranking member Patty Murray (D-Wash), have said they won't support the medical innovation package without additional, mandatory NIH funding. Alexander said he favors a one-time funding surge to support specific projects in precision medicine, the cancer “moonshot” initiative, brain research, support for young scientists and big “biothink” awards for large, innovative projects.
“I can assure that you I don’t have any intention of taking the work product of this committee to the floor without a bipartisan agreement with Senator Murray and others about the surge of funding for the National Institutes of Health,” Alexander said. “Without that agreement, we don’t get this bill. But without this bill, we don’t get mandatory funding either.”
HELP Committee leaders have consulted with the chairman and ranking member of the Senate Finance Committee as well as Health and Human Services Secretary Sylvia Mathews Burwell, he said.
Murray said she believes the committee can reach a bipartisan agreement, and once that's reached, “we'd be able to make a real difference in the lives of patients and families across the country.”
Besides funding, Alexander said, other issues that still need to be resolved are:
“These are some of the remaining issues, but the fact remains that we began with 50 bipartisan issues,” Alexander said. “So we’ve made substantial progress.”
The bills approved by the committee during the April 6 markup were:
Four of the five bills moved forward on a voice vote. Senators approved the precision medicine bill (S. 2713) by a 20-2 vote, with Warren and Sen. Rand Paul (R-Ky.) voting against the bill.
The HELP Committee also approved several amendments to the bills, including one from Sen. Pat Roberts (R-Kan.) over concern that the FDA is relying too heavily on guidance documents instead of using the rulemaking process. Roberts' amendment would require the FDA to justify why it's issuing a guidance document as opposed to formal rulemaking, whenever the FDA issues a new guidance that provides initial interpretations of new significant regulatory requirements.
The committee approves an amendment requiring the FDA to justify why it's issuing a guidance document as opposed to formal rulemaking in certain cases.
“My intent is not to prohibit the agency from issuing guidance. They aren’t all bad. They are vital to industries the FDA regulates,” Roberts said. “But they must be used appropriately—to guide, not to implement new policies and avoid the requirements of the formal rulemaking process.”
Murray said she couldn't support Roberts' amendment because FDA Commissioner Robert M. Califf expressed concerns that such a requirement would slow the FDA's ability to relay information quickly and efficiently, especially when there is a public health risk.
The FDA guidance language was one of two amendments HELP members attached to S. 2700. The other amendment from Sens. Richard Burr (R-N.C.) and Robert P. Casey Jr. (D-Pa.) would waive the Department of Health and Human Services' requirements under the Paperwork Reduction Act during a public health emergency.
The committee also approved an amendment to S. 2713 to protect the genetic privacy of research participants. Warren, who sponsored the amendment with Sen. Michael B. Enzi (R-Wyo.), said the privacy laws need to be updated as researchers are collecting more and more information to help understand diseases and develop the next generation of cures.
“It will give more people reassurance that participation in clinical trials won’t compromise their privacy,” she said.
Warren, who has said she won't vote in favor of any medical innovation bills without guaranteed mandatory funding for the NIH, voted in favor of the amendment but against S. 2713.
The committee also approved an amendment to S. 2742 from Burr that would require the NIH's National Center for Advancing Translational Sciences to include in its annual report any methods and tools that have been developed with NCATS-supported research.
To contact the reporter on this story: Jeannie Baumann in Washington at email@example.com
To contact the editor responsible for this story: Brian Broderick at firstname.lastname@example.org
More information on the markup is available at http://www.help.senate.gov/.
Warren and Enzi's genetic privacy amendment is at https://www.congress.gov/bill/114th-congress/senate-bill/2744.
Roberts' amendment on FDA guidance is at http://src.bna.com/dUR.
Burr's NCATS amendment is at http://src.bna.com/dVh.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)