United States: Proposed FDA Overhaul To Improve Biomedical Discovery And Development

The House of Representatives and the Senate are assessing significant reforms to the Food, Drug and Cosmetic Act. The reforms are aimed at accelerating the approval of new drugs, medical devices and other products regulated by the Food and Drug Administration (FDA). On January 27, 2015, the House Energy and Commerce Committee released draft legislation. On January 29, 2015, the Senate Health, Education, Labor and Pensions (HELP) Committee released the "Innovation for Healthier Americans" report. If legislation of the proposed scope were enacted, it would be the most significant healthcare reform law in the United States since the Affordable Care Act.

The Energy and Commerce Committee's draft bill is the product of the 21st Century Cures initiative, a year-long bipartisan effort focused on streamlining the FDA regulatory review process, incentivizing stakeholder opportunities to innovate and incorporating patient experience data in evaluating the risks and benefits of new treatments. Chairman Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.) have led the initiative, and the Energy and Commerce Committee collaborated with the National Institutes of Health (NIH), FDA and other agencies; academia; and industry. The committee's objective is to present a bill to President Obama for signature by the end of 2015.

After five white papers, eight hearings and numerous roundtables convened in 2014, the draft legislation is the initiative's first concrete step to address the challenges of drug and device development in a number of key areas. One of the most notable aspects of the proposed legislation is provisions designed to modernize the agency's regulatory pathways to expedite breakthrough approvals of medical treatments and technologies. Section 1222 of the draft legislation provides that most drugs would receive protection from generic competition for 15 years, an increase from five years for new chemical drugs, seven years for rare-disease drugs and 12 years for new biologic medicines. Additionally, Section 1041 would permit the FDA to approve drugs designated as "breakthrough therapies" for serious or life-threatening diseases or conditions on an accelerated pathway. Similarly, Section 1081 would provide an accelerated pathway for breakthrough medical devices. The draft legislation also includes special, narrow approvals for antibiotics. Section 1061 would establish a new pathway for the FDA to approve antibiotic therapies through a "limited population pathway," to increase approvals of antibacterial and antifungal drugs.

The Senate HELP Committee's report addresses unnecessary regulatory burdens and proposes ways to facilitate stakeholder engagement to accelerate medical innovation. Chairman Lamar Alexander (R-Tenn.) and Sen. Richard Burr (R-N.C.) have started a major health initiative including a bipartisan working group and series of hearings to examine the time and cost associated with the drug and medical device development process. Sen. Alexander stated, "The challenge is that our process for developing and reviewing these products is out of date and unable to match the pace of discovery, so American patients are waiting too long for relief." The report identifies issues to examine, including allocation of government resources, clinical trial requirements, biomedical research, public-private partnerships, the FDA approval process and international regulations.

Initial response to the Energy and Commerce Committee's draft legislation underscores the difficulty of addressing the competing interests of multiple stakeholders. Several industry stakeholders have offered their support for the initiative. In particular, the Association of Clinical Research Organizations released a statement that the draft legislation "provides the outline for a solid framework" to "enhance data sharing and make greater use of real world evidence, streamline the review process for clinical trials, and make clinicaltrials.gov a more useable tool for patients, and physicians and researchers." Additionally, the Biotechnology Industry Organization offered support for the initiative stating that it addresses "the need for a large-scale national research commitment to study precursors and signs of disease and disease risk factors for chronic conditions," with a focus on precision medicine through genomics and regulatory science.

Yet, the momentum of bipartisanship has cooled from concerns raised by Democrats in the Energy and Commerce Committee. Rep. DeGette stated that she does not endorse the draft but hopes "to reach a bipartisan consensus to help advance biomedical research and cures." Meanwhile, Rep. Frank Pallone, Jr. (D-N.J.), a ranking member of the committee stated, "In its current form, I am concerned that the nearly 400 page draft could create more problems for our healthcare system than it solves." While there is bipartisan support for many of the health IT provisions, Democratic leaders also disliked several pharma- and NIH-related provisions that seek to speed the movement of drugs and medical devices through the FDA.

The committees seek feedback on the House draft legislation and the Senate report. Although there is no specified deadline for feedback on the draft legislation, feedback on the Senate report is due by February 23, 2015.

Lowell Zeta contributed to this article.

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