After three years of imagining the possibilities, U.S. lawmakers are now wheeling and dealing to get the 21st Century Cures Act signed into law before the 114th Congress fades into the sunset.
The House, which approved a Cures bill last year on a vote of 344-77, plans to vote Wednesday on a revised $6.3 billion, 996-page package that will be offered as an amendment to unrelated legislation already passed by the Senate. (See BioWorld Today, July 13, 2015.)
The latest iteration of Cures will include updates to mental health programs and $1 billion for state grants to fight the growing opioid epidemic. The package also provides $500 million in increased funding for the FDA and $4.8 billion for the NIH. The NIH funding includes $1.4 billion for the Precision Medicine Initiative, $1.8 billion for the Cancer Moonshot and $1.6 billion for the BRAIN Initiative. What's missing is a proposal that would have created a mandatory pot of research funding for the NIH.
Sen. Elizabeth Warren (D-Mass.), a member of the Senate Health, Education, Labor and Pensions (HELP) Committee, has warned repeatedly that a final Cures package won't pass the Senate unless it has mandatory NIH funding. At a hearing in April, HELP Chairman Lamar Alexander (R-Tenn.) said he would continue to work toward getting an NIH innovation fund included in the package before it came up for a vote before the full Senate. He added that the trick would be finding a dollar amount that's doable and that everyone in both the House and the Senate could agree on. (See BioWorld Today, March 10, 2016, and April 7, 2016.)
The Senate has been the stalling point for Cures. Rather than taking up the bipartisan Cures bill passed by the House last year, the HELP Committee insisted on crafting its own, more restricted, medical innovation package. However, this time around, Alexander has joined Rep. Fred Upton (R-Mich.), one of the driving forces behind the House bill, in pushing for final passage of Cures.
Senate Majority Leader Mitch McConnell (R-Ky.), calling Cures "the most important legislation Congress will consider this year," has promised that once the House passes the new version, the Senate will vote on it before the end of December.
Designed to close "the major gaps between the science of cures and the way that we actually regulate these therapies," the bill addresses issues across the full arc of drug and device discovery, development and delivery, Upton and co-sponsor Diana DeGette (D-Colo.) said.
While a few changes are likely before the bill hits the House floor this week for a vote, key provisions in the draft released Friday are intended to bring drugs and devices to market more quickly and at less cost by expediting the review of breakthrough devices, increasing patient involvement in the drug approval process, streamlining the review process for drug/device combination products and cutting through the regulatory red tape for certain fitness and nutritional software apps.
The bill also would:
To offset the costs of the provisions, the bill would rely on savings from a disease prevention fund created in 2010 as part of the Affordable Care Act and the sale of oil from the nation's Strategic Petroleum Reserve.
While some groups will be disappointed that the package doesn't address drug pricing, the response to the revisions has been generally positive. Chip Davis, president and CEO of the Generic Pharmaceutical Association (GphA), recognized it as "a bipartisan achievement that should spur innovation and benefit patients." He urged Congress to quickly pass the bill. (See BioWorld Today, Oct. 28, 2016.)
At the same time, Davis reminded Congress that the work will not end with Cures. "While the 21st Century Cures Act released [Friday] does not include provisions GPhA supports to increase prescription drug pricing competition, we will continue working with Congress to find solutions to rising drug costs," Davis said.
A number of bills dealing with drug-pricing issues are likely to be revived in the next Congress as it renews the various FDA user fee agreements. Davis said GPhA would continue to work for passage of legislation such as the CREATES Act and the FAST Generics Act that are intended to remove hurdles to the timely development and marketing of generic drugs.
Scott Whitaker, president and CEO of the Advanced Medical Technology Association, also applauded the Cures legislation. "The package includes a number of important improvements to FDA's medical device premarket program designed to increase the efficiency, predictability and transparency of the agency's review process," he said.
JCCT LEADS TO TRADE PROGRESS
In wrapping up the 27th U.S.-China Joint Commission on Commerce and Trade (JCCT) meetings last week, the U.S. Trade Representative (USTR) claimed progress on the drug and medical device front.
As a result of the ongoing JCCT dialogue, China has committed to strengthening its oversight of government procurement of devices and to treating overseas products in a transparent, fair and equitable manner, according to the USTR.
China's government policies encouraging the domestic development of devices will not discriminate against or exclude products manufactured overseas. Instead, they're intended to improve the quality and standard of domestic medical devices and to establish cooperative platforms for government, industry, academic, research and medical institutions. As part of its commitment, China pledged to listen to industry and relevant stakeholders as it continues to develop and adjust its Medical Device Clinical Trial Exemption Catalogues.
In establishing its unique device identification (UDI) and traceability system, China said it would consider international standards, globally accredited issuing agencies and other international UDI guidelines. It plans to offer a phased-in, risk-based implementation approach, with an initial implementation period for phase I of no less than two years. Devices manufactured or labeled prior to the rule's effective date would be exempt under the proposal.
China also is working on policies, regulations and technical requirements to improve its drug registration review and approval process, so approved applicants could conduct parallel clinical trials within and outside of the country. Another change would allow overseas drug manufacturers to supplement the certificate of pharmaceutical product when applying for a drug marketing license. In addition, China affirmed that its drug registration review and approval will not be linked to pricing commitments and will not require specific pricing information.
The USTR said the JCCT outcomes will facilitate greater U.S. drug and device exports to China. As it is, the U.S. is the leading supplier of medical devices to China in all product areas, with exports valued at $4.2 billion in 2014. With about $18 billion in device sales last year, China is the fourth largest medical device market in the world. Those sales are expected to grow to $27 billion, or 8.7 percent, by 2020.
Even bigger growth is expected for drugs in China. Currently the world's second largest biopharmaceutical market, China's demand for medicines is forecast to grow from $108 billion last year to $167 billion by 2020, a 9.1 percent increase.