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FDA proposes greater cooperation with its ‘stakeholders’


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There must be ways that federal regulators and their external “stakeholders” can collaborate on projects that can help to ensure the safety of pharmaceutical products. The U.S. Food and Drug Administration, which appears to believe so, wants to tap into a reservoir of external scientific research to meet its regulatory needs.

Hence, the FDA on March 19 issued a Federal Register notice that “asks stakeholders conducting research related to these needs to describe that research and indicate their interest in collaborating with FDA to address safety-related research priorities.”

The agency defines “stakeholders” and explains its mission succinctly in its July 2011 report describing the scientific priorities of the FDA. The report reads, in part, “We have successfully partnered with academics, industry, other government agencies and nonprofits on many initiatives and would like to explore opportunities to expand these collaborations.”

Back in 2011, an FDA subcommittee identified several needs that external scientific research, from the pharmaceutical industry and from other stakeholders, can help the FDA to meet:

1. Improve access to post-market data sources and explore the feasibility of their use in safety signal analyses

2. Improve risk assessment and management strategies to reinforce the safe use of drugs

3. Evaluate the effectiveness of risk communications of drug safety information to health care providers and the public

4. Improve product quality and design, manufacturing processes, and product performance relating to safety

5. Develop and improve predictive models of safety in humans, including nonclinical biomarkers

6. Improve clinical trial statistical analyses for safety, including benefit-risk assessment

7. Investigate clinical biomarkers of safety, including standards for qualification

The FDA is asking its stakeholders, therefore, to “submit descriptions of their ongoing research and initiatives related to the seven overall needs, especially the identified priorities, and indicate their interest in working with FDA to address these needs.”

Let’s hope the FDA’s attempt to collaborate with external sources to help meet its regulatory needs will pay off. One this is certain: The pharmaceutical industry needs to be forthcoming about the quality of research into its own products. The FDA’s efforts will be futile if clinical trial data do not tell the whole story.

For instance, as this blog space reported weeks ago, the medical journal JAMA Internal Medicine released a report in February covering the FDA’s inspection of clinical trial data that drug makers use to point to the safety of their products. Half of the agency’s inspections of sites involved in clinical trials of the blood thinner rivaroxaban, which goes by the brand name Xarelto, showed irregularities.

The article reported, “These inspections had uncovered evidence of various transgressions, such as ‘systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization.’ Consequently, the entire study, RECORD 4 (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep-Venous Thrombosis and Pulmonary Embolism 4) was deemed unreliable by the FDA.”

Xarelto was one of those drugs that slipped through the empirical cracks. And Reich & Binstock and other law firms have been representing victims or the family members of decedents nationwide whose health succumbed to an allegedly unreasonable risk of uncontrollable bleeding.

If the FDA and its stakeholders can exchange scientific data more efficiently and can collaborate on research projects, ideally public health will benefit. Perhaps fewer drugs someday will generate adverse effects that will point to an unreasonable risk of injury that the manufacturer should have known about and should have minimized. Those are the most important things.

In the meantime, any Xarelto patient who has experienced a serious bleeding injury may contact Reich & Binstock for a free consultation either by calling the toll-free number, 1-866-LAW-2400, or by submitting an electronic message through this web page.

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