House Passes 21st Century Cures Act, Companion Bill in Works in Senate

The House of Representatives on July 10 approved the 21st Century Cures Act by a vote of 344 to 77, moving focus to the Senate where efforts have begun to develop comparable legislation.

Sen. Lamar Alexander (R-Tenn.), chairman of the Senate HELP Committee, has said his committee is crafting legislation. “The HELP Committee is working on a bipartisan basis on this initiative and currently has five working groups meeting on a variety of FDA and NIH issues relating to drug and device innovation, from research to approval,” spokeswoman Margaret Atkinson tells CTA.

Peter Pitts, president of the Center for Medicine in the Public Interest, says the Senate could pass legislation by the fourth quarter of this year.

The massive overhaul bill would encourage broader use of observational studies, patient registries and actual therapeutic use to support approvals of new drugs and enhance postmarket surveillance, allow for greater use of innovative statistical methods in clinical trial designs and provide an extra six months of marketing exclusivity when drugmakers adapt existing products to treat rare diseases — beyond the seven years of exclusivity drugs get when granted orphan product status.

To speed access to novel therapies, drugmakers would be guaranteed FDA approval if investigational products met intermediate endpoints in an agreed-to development plan. The bill also directs the FDA to issue guidance on acquiring clinical evidence on different categories of drugs outside randomized clinical trials (CTA, June).

The Congressional Budget Office estimates that provisions in the bill, if implemented by the FDA, would cost $270 million from 2016 to 2020, according to a report issued June 23. Key provisions affecting research and development include:

  • $33 million to establish a process to qualify or validate certain drug development tools such as biomarkers;
  • $21 million to implement a program aimed at providing incentives to drug companies to develop new indications for drugs and biologics that target rare diseases and conditions and extending the voucher program for rare pediatric diseases through Dec. 31, 2018;
  • $20 million to develop a regulatory structure to allow the use of new protocols for statistical modeling and trial designs to support marketing applications for drug and biological products;
  • $18 million to devise a plan with sponsors of drugs and biologicals eligible for accelerated approval to agree on details of the clinical study design so that approvals can be expedited; and
  • $14 million to establish a streamlined data review program to allow sponsors to submit qualified summaries of clinical data to support approval or licensure of new indications under certain circumstances.

The CBO report can be read here www.fdanews.com/06-24-15-cboreport.pdf.
— Jonathon Shacat and John Bechtel

 

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