Alexander Tells FDA To Create ‘Red Team’ For Regulatory Streamlining
This article was originally published in The Tan Sheet
Executive Summary
HELP Committee Chairman Lamar Alexander wants FDA to suggest regs and other bureaucratic requirements that are hindering productivity as part of medical innovation effort.
FDA might have a chance to eliminate some of the red tape that irritates staff and hinders productivity in the name of speeding new drugs to market.
As part of the Senate’s effort to move innovative medical products to patients faster, Sen. Lamar Alexander, R-Tenn., asked FDA and the National Institutes of Health to prepare a list of regulations and other rules or requirements the agencies feel slow their work.
Alexander, chairman of the Health, Education, Labor and Pensions Committee, told NIH and FDA officials during an April 28 hearing the legislation that will emerge from the process is an opportunity to “clear the clutter out of the way.”
“We want to align federal policies, and that means our laws and our regulations, with an opportunity for more, not less, safe innovation,” he said. “I would invite each of you to form your own internal red team for red tape and if you see things that are in the law or in regulation or even if the Office of Management and Budget makes you do and you think are nonproductive, let us know.”
Alexander wants the agencies’ lists in the next few months. A bipartisan working group will take the suggestions into account and potentially recommend some for the bill.
Janet Woodcock, director of the Center for Drug Evaluation and Research, said after the hearing that FDA should be able to offer a list of burdensome regulations.
Woodcock also reminded committee members to be careful when crafting the bill to ensure their good intentions do not make FDA’s job tougher.
“When CDER receives a large number of unfunded mandates, our attention can be diverted and [drug] review performance suffer,” she said. “As we consider actions to enable innovation we need to make sure that we don’t break what is working, but that we improve on the current system.”
A move to remove red tape also should resonate with House members, who are working on similar legislation with mostly the same intentions.
The House Energy and Commerce Committee is on a faster track with its legislation, however. The committee is expected to release a discussion draft of its 21st Century Cures bill this week and its Health Subcommittee has scheduled an April 30 hearing to discuss it (Also see "FDA Hoping To Shift Some ‘Cures’ Initiatives Toward User Fee Negotiations" - Pink Sheet, 21 Apr, 2015.).
The HELP Committee hearing was its third related to its medical innovation push, which is moving on a parallel track to 21st Century Cures initiative (Also see "Slower FDA Review Divisions Draw Attention At Senate Hearing" - Pink Sheet, 25 Mar, 2015.).
A fourth hearing has been scheduled for. May 5 to discuss precision medicine. President Obama called for an increase in research and development funding for precision medicine in his State of the Union speech (Also see "‘Precision Medicine’ Gets R&D Funding Push In President’s Speech" - Pink Sheet, 21 Jan, 2015.).
Where Should FDA Start?
Woodcock’s toughest job may be choosing regulations to suggest be adjusted or eliminated.
FDA officials have complained many times over the years about regulations or unfunded mandates that stress staff or shift resources away from approving drugs and other medical products.
Among the recent problems was creation of the Risk Evaluation and Mitigation Strategies. Intended to help FDA better manage drug risks, it ended up creating headaches for the agency and drug application sponsors.
After problems surfaced following its creation in the 2007 FDA Amendments Act, Congress included provisions in the 2012 FDA Safety and Innovation Act to require FDA to determine ways to better integrate REMS into the health care system (Also see "FDA Simplifies The Process For REMS Changes" - Pink Sheet, 6 Apr, 2015.).
FDAAA included so many changes that Office of New Drugs Director John Jenkins allowed reviewers to miss user fee goals temporarily during the adjustment period (Also see "The Good Old Days: FDA's Jenkins Instructs Reviewers To Meet Original User Fee Review Time Standard" - Pink Sheet, 7 Dec, 2009.).
The breakthrough therapies program, created in FDASIA, also has proven to be a burden on FDA, in part because of its popularity.
Far more designations have been issued than were expected and FDA officials have said the attention necessary for it and other review programs may force it to let some items slip (Also see "FDA Strains Under New NDA Review Model; Will Industry Want To Retain It?" - Pink Sheet, 16 Dec, 2013.).
Neither REMS nor breakthrough designations are going away, of course, but what FDA puts on its regulatory streamlining list could indicate how cooperative the agency is being in this stage of the regulatory reform effort.
At a previous Senate hearing, former FDA Commissioner Margaret Hamburg fielded essentially the same question, about where she would like to reform the agency, and her answer basically boiled down to a request for more funding (Also see "FDA’s Top Two Reform Priorities Aren’t Really Legislative Material" - Pink Sheet, 16 Mar, 2015.).
Hamburg’s acting successor, Stephen Ostroff, has struck a more conciliatory tone when discussing the legislative efforts (Also see "FDA Hoping To Shift Some ‘Cures’ Initiatives Toward User Fee Negotiations" - Pink Sheet, 21 Apr, 2015.).
For NIH, Director Francis Collins already told House members requirements in the Paperwork Reduction Act are a problem, as are existing pay and travel restrictions (Also see "Rx Exclusivity Provisions In 21st Century Cures Expected To Spur Controversy" - Pink Sheet, 10 Feb, 2015.).
Funding Still Plays A Role
Alexander made clear during the hearing that the committee is aware funding increases are a significant part of the suggested legislative fix.
Several Senators during the hearing also raised the issue in the context of NIH, saying they saw support for basic research as one of the requirements to spur new innovative treatments.
Funding would be dealt with in the Appropriations Committee and to some extent the HELP Committee as well, Alexander said.
However, it may be that any streamlining efforts produce the bulk of the extra money available for the project, at least for FDA.
House Republicans already have indicated that FDA likely will not see much, if any, budget increase in fiscal year 2016.