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The revised "21st Century Cures” proposal includes provisions for research for continuous manufacturing, biomarker development, and NIH funding.
Amidst its multiple provisions for stimulating drug development and revising drug regulatory processes, the 21st Century Cures initiative includes a provision to encourage the adoption of continuous manufacturing systems for drugs and biologics. A small paragraph in the latest draft of the measure authorizes FDA to award grants to academic institutions and nonprofit organizations to study and recommend improvements to such production methods and other “innovative monitoring and control techniques.” The proposal leaves open the amount of funding for the program, which ultimately would require agreement from Congressional appropriations committees.
The manufacturing provision specifically addresses efforts by FDA’s Center for Drug Evaluation and Research (CDER) to encourage greater industry investment in quality drug production methods, and it drew strong praise from CDER director Janet Woodcock at an April 30 hearing before the House Energy & Commerce (E&C) Committee. Woodcock noted that current batch-production systems provide tremendous opportunities for waste and errors, while continuous manufacturing “is the future of drug manufacturing” and has the potential to bring more pharmaceutical production back to the United States.
Woodcock acknowledged there is a high cost to switching to new manufacturing technologies, and that generic drug manufacturers, with lower profit margins, may take a while to make such investments. But she observed that the innovator pharmaceutical industry understands the opportunity here and is “moving briskly” to adopt new systems to ensure product quality.
Woodcock’s main concern with the revised “Cures” draft is that it requires FDA to establish new programs and issue more guidance without providing additional resources to support these efforts. This latest E&C proposal has “significant resource implications for FDA,” Woodcock stated, pointing out that more new mandates could divert resources from application review and biomarker development. CDER’s new drug review process is now “going at full speed, and we’d like to keep it that way,” Woodcock commented, noting that “there’s always a trade-off” in putting out new guidances and getting reviews done. Being able to offer timely advice to biopharma companies helps accelerate new drug development, she noted, but support for multiple advisory meetings “would be the first to go” if the agency gets further stretched on resources.
Also controversial in the draft bill is a provision that allows biopharma companies to use “clinical experience” rather than data from randomized trials to support new indications. The proposal also permits FDA to quickly approve expanded uses based on data summaries, rather than the full data package. And there are proposals to permit pharma companies to communicate economic information to formulary committees and payers and to make it easier for marketers to distribute journal articles and medical textbooks.
Major changes in the new E&C proposal include a significant boost in funding for the National Institutes of Health (NIH) and deletion of earlier provisions that provide added exclusivity for certain new biopharmaceutical therapies. The legislation authorizes a $5 billion increase in NIH funding over three years, to provide a budget of $35 billion in 2018. And there’s another $2 billion a year to support an NIH Innovation Fund. Democrats pressed hard for increased funding for NIH research, and also opposed extended exclusivity on new drugs. The result is that leading Democrats on the E&C Committee announced their support for the revised measure, setting the stage for possible legislative action by summer.