Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...
Sept. 9 — The Senate's medical innovation bill is likely to include reforms and possible funding for the NIH in addition to updating the drug and device regulations at the FDA, a Senate Democratic staffer said during a Sept. 9 press briefing.
Largely considered the parallel effort to the House-passed 21st Century Cures bill (H.R. 6), the Senate's bill on drug and device innovation hasn't been introduced yet. But the Senate is still on track to have a bill approved by the Senate Health, Education, Labor and Pensions Committee by the end of the year, with a floor vote expected early next year, the staffer said.
The Senate aide, who spoke on the condition of not being identified, said there will be some provisions in the Senate version that weren't in the House bill, but there will be many overlapping provisions because both bills have the overall goal of “looking at reforms of how innovative medical products can get to patients quicker while at the same time maintaining the gold standard of quality and safety and efficacy that Americans have come to rely on.”
The House Energy and Commerce Committee describes H.R. 6 as an effort to speed the discovery, development and delivery of life-saving and -improving therapies. The full House approved the legislation in July.
While no companion bill has been introduced in the Senate, a draft version is expected this fall.
“They generally occupy the same real estate or the same ZIP code,” the Senate staffer said about the work in both chambers at a press briefing on health policy on Capitol Hill, which was organized by the Alliance for Health Reform.
Since February, Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), who are the chairman and ranking member of the HELP Committee, respectively, have led a number of staff-led working groups on the medical innovation initiative that have covered a broad array of topics. The Senate aide said HELP Committee staffers are narrowing those topics for the bill, a process the aide said will mature over the next month.
• drug regulations,
• medical device regulations,
• responses to antibiotic-resistant strains of bacteria,
• making the hiring process at the Food and Drug Administration more flexible,
• the FDA's authority over laboratory developed tests; and
• a series of reforms to the National Institutes of Health “that don’t do any major surgery … but certainly increase efficiencies” and decrease administrative burdens.
“Those are some of the big buckets that we are focusing in on,” the aide said. “We’re working hard over the next few weeks, and I think you’ll see the eventual package stay generally within those guardrails.”
The Senate aide said the medical cures innovation bill will be the Senate HELP Committee's “biggest piece of work on the health side.” While acknowledging that “anything could slip,” the staffer said the committee staff has a good internal timeline to keep moving forward with the bill.
A House Republican staffer, who was part of the same panel, agreed with the Senate Democratic aide.
“Pay attention to Cures,” the House aide said. “I still think it’s important even in a presidential year.”
While Congress doesn't want to push too many legislative items into 2016 because of the presidential election, the House aide said these bills have attracted a large number of votes and have the ability to move forward.
“It’s good policy. It's feel good,” the House aide said.
The Senate aide said there will certainly be provisions that differ “significantly” between the Cures bill and the Alexander-Murray legislation, and said he was optimistic that those changes could be worked out in conference. The aide also identified what has been one such issue, and that's the question of whether the $8.75 billion in mandatory spending that the House provided for the NIH will carry over to the Senate. The Democratic aide noted that the NIH funding was “such a huge part of the overwhelming bipartisan support that bill got.”
“We’re looking to replicate that overwhelming bipartisan support on our side through a similar sort of formula, so it shouldn’t be a brooding, bloody conference process,” the Senate aide said.
In addition to the medical innovation bill, the Senate aide said there will likely be some work in health information technology—including a HELP Committee hearing scheduled for Sept. 16—on ways to improve both the provider and the patient experience. The aide also said the Senate committee will continue its work in mental health in the next several weeks and work on the bill (S. 928) to reauthorize the World Trade Center Health Program and the September 11th Victim Compensation Fund of 2001, and for other purposes.
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 briefings by the Alliance for Health Reform is available at http://www.allhealth.org/.
More information on 21st Century Cures is available at http://energycommerce.house.gov/cures. More information on the Senate HELP Committee's work in medical innovation is available at http://1.usa.gov/1UHvtAy.
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)