Coalition Calls on FDA to Follow EMA’s Lead and Offer Scientific Opinions on Use of Drugs Outside US

Regulatory NewsRegulatory News | 21 April 2016 |  By 

As part of efforts to streamline and strengthen regulatory pathways for global health products, the Global Health Technologies Coalition (GHTC) says in a new report issued Thursday that Congress should direct the US Food and Drug Administration (FDA) to establish a specific mechanism to offer a formal scientific opinion on medical products for their use outside the US.

Because FDA is classified as a stringent regulatory authority, the agency’s review of drugs and devices can help facilitate and streamline reviews by both WHO’s Prequalification Program and lower-resourced national regulatory authorities in other countries, GHTC says.

And adding a mechanism for formal scientific opinions, the coalition claims, would permit FDA to offer its stance on the safety, efficacy and manufacturing quality of drugs, vaccines and other health technologies for their use outside the US.

Under-resourced regulatory authorities in low- and middle-income countries (LMICs) would then have the scientific knowledge they need to enable more informed national-level regulatory reviews.

“The European Medicines Agency (EMA) has a similar mechanism, known as Article 58, which allows the EMA to offer a scientific opinion on products that will be used exclusively outside the European Community. This program, which is intended to help facilitate regulatory review in LMICs and is operated in close coordination with WHO, could serve as a model for a US mechanism,” GHTC says.

Neglected Tropical Diseases

In addition, GHTC is calling on Congress to explicitly incorporate neglected tropical diseases (NTDs) into existing FDA pathways and programs for rare and orphan diseases.

“NTD product developers face similar challenges to developers for rare and orphan diseases, including limited commercial market potential and limited resources or expertise to navigate regulatory review,” GHTC says. “While many NTDs meet the definition of a rare or orphan disease, as codified in the Orphan Drug Act of 1983, orphan and rare disease programs do not explicitly identify NTDs as within their scope. This lack of clarity might discourage NTD product developers from pursuing use of these programs, and may discourage the FDA from supporting NTD products through these programs due to jurisdictional concerns.”

FDA should explore a model similar to the Emerging Infectious Disease Task Force and Ebola Task Force to facilitate a more coordinated approval process for health technologies needed to address endemic and longstanding infectious disease threats, the coalition says. 

GHTC also calls on Congress should get creative in crafting new incentives or reforming existing ones, like the Priority Review Voucher program, to encourage increased private-sector participation and investment in global health research and development.

“New targeted and strategic incentive mechanisms, like prizes, advanced market commitments, and tax credits will help incentivize greater private sector engagement in R&D for neglected global diseases and conditions and bridge the divide between need and availability. In cases where mechanisms already exist, like the FDA Priority Review Voucher—which rewards companies that develop and secure FDA approval for technologies addressing NTDs with a transferrable or sellable voucher for expedited FDA regulatory review of another product—Congress should monitor these mechanisms to ensure they are effectively encouraging new investment in neglected disease R&D and promoting affordability and access to lifesaving technologies.”

GHTC 2016 Policy Report



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