Bill Could Increase Patient Influence in Drug Development Process

Bill Could Increase Patient Influence in Drug Development Process

 In Government Relations, Stakeholder Engagement

Patients and advocacy groups may be one step closer to increasing the strength of their voices in the development of new treatments.

A bill designed to spur biomedical innovation and place patients more squarely in the center of FDA decision-making processes has just cleared a major legislative hurdle. The 21st Century Cures Act, a piece of legislation that would require the FDA to integrate patient input and real-world evidence data into its regulatory decisions, was approved on May 21 by the U.S. House of Representatives’ Energy and Commerce Committee.

Passage of the bill would elevate patients’ role in the drug development conversation, which could help to ensure that the FDA prioritizes drugs that meet unmet needs in the patient community and reflect patients’ treatment priorities. Stakeholders have noted that the legislation could increase focus on patient-centric issues.

Patient advocacy groups would have a key role to play in educating patients about the change in the law, and organizing and submitting patients’ input to the FDA. Strong outreach and education programs from patient advocacy groups would be essential to ensuring that patient priorities are heard during the drug development process.

But groups can’t begin putting their patient outreach programs in place quite yet. The bill is far from final, and will have to clear votes in both the House and the Senate before it becomes law. According to news reports, voting could begin as early as June.