Biomedical R&D Faces New Regulatory Policies and Priorities


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-12-01-2016
Volume 25
Issue 12

With a new administration in Washington, sponsors and regulators are weighing several initiatives that promise to reshape clinical research policies.

As Donald Trump prepares to move into the White House, and Republicans consolidate their control in the House and Senate, clinical research sponsors and regulators are weighing a host of initiatives that promise to reshape policies governing biomedical R&D and regulations for developing and testing new therapies. Pharmaceutical and biotech companies may feel some relief that Trump’s victory will head off a concerted attack on drug prices and marketing. Industry also could gain billions from promised tax reform, which could fuel a new wave of mergers and acquisitions likely to stimulate medical product development.

But reduced funding for the National Institutes of Health (NIH), the FDA and independent research centers could limit the basic research that is critical to medical product discovery and undermine an efficient and innovative drug regulatory process. And the demise of the Trans Pacific Partnership (TPP) trade pact and other international trade agreements could block imports of critical pharmaceutical ingredients from China and other nations and limit pharma research programs and sales overseas.

Action to “repeal and replace” the Affordable Care Act (ACA), moreover,  could roll back expanded drug coverage and prescribing, and the resulting revenues needed to fund research programs. Eliminating  all the ACA mandates and requirements may be hard to actually accomplish, as health policy experts on all sides recognize that unless healthier patients stay in exchange plans, insurance costs would “death spiral” out of control.

Regulatory reform ahead

A popular Republican theme is to rein in government regulation that hinders private sector innovation and economic growth. Trump policy advisers are looking to reverse aspects of healthcare, consumer protections and environmental policies through legislation and regulatory reform,  and FDA rules related to food safety and consumer product use are high on the list. New policymakers also may be less enthusiastic about expanding research transparency and data sharing, which have raised concerns from industry about premature disclosure of proprietary information.

The president-elect early on voiced support for advancing healthcare R&D and for making changes at FDA to support the “need of patients for new and innovative medical products.” Trump also has called for more expeditious FDA approval of new and generic drugs to promote patient access to needed treatments and provide competition that can help hold down drug prices.

Those goals could lead to positive initiatives, such as incorporating patient perspectives into research protocols, greater acceptance of real-world evidence, broader use of innovative clinical trial models and further emphasizing the benefits as well as risks of innovative research methods.

As the Trump administration maps out federal funding and budget priorities, the biomedical research community will get a clearer picture of its support for R&D, including the precision medicine and cancer moonshot initiatives. NIH’s $30 billion budget has shrunk in real terms in recent years, but the new administration may not want to see China’s R&D investment outpace that of the U.S.

The choices for HHS secretary and a new FDA commissioner and NIH director also will signal the administration’s approach to maintaining a robust research enterprise that fuels the medical products pipeline. One danger is that changes in FDA leadership could prompt notable turnover in the agency’s senior staff, particularly if FDA officials anticipate a new wave of antagonistic queries from Congressional investigators. Another major concern is that a federal hiring freeze would shut down FDA efforts to fill hundreds of current vacancies in review staffs.

A shake-up at FDA, though, would upset industry, which is fairly satisfied with agency progress in meeting application review goals and in streamlining medical product testing policies. The need to renew FDA user fee programs for drugs, generics, biosimilars and medical devices before they expire Sept. 30, 2017 provides a ready vehicle for the new administration to advance policies that enhance FDA programs and policies. A broad FDA bill may include measures to combat the nation’s opioid crisis, to facilitate patient requests for early access to experimental medicines and to liberalize manufacturer communications on off-label uses of medical products.

Policymakers also may look to add drug pricing provisions to user fee legislation. Trump has supported importation of certain high priced drugs and authority for Medicare to negotiate rates for expensive therapies. Other proposals would boost Medicaid rebates on products that increase prices faster than inflation and require greater transparency in the process for setting drug prices, rebates and patient copays, including the role of pharmacy benefit managers in influencing rates and patient outlays. User fee reauthorization legislation needs to be moving through Congress by June to avoid interrupting FDA’s medical product approval process, but could bog down if policy makers overload it with too many controversial provisions. 

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