In addition to receiving a nearly 3% increase in budget over initial proposals from congressional committees, FDA also will see the rare pediatric disease priority review voucher program continue in the new budget deal.

The omnibus appropriations bill, posted early Dec. 16, would provide $4.68bn to FDA in fiscal year 2016, which is $238 million more than the agency received in a December 2014 continuing resolution that funded the government for FY 2015 (see interactive graphic at the end of the story).

And among the general provisions was an extension of the popular voucher program through the end of fiscal year 2016.

The bill would change existing language prohibiting the agency from awarding vouchers “after the last day of the one-year period that begins on the date the secretary awards the third rare pediatric disease priority voucher” to simply state no vouchers may be awarded after Sept. 30, 2016.

Vouchers would be available for another six months, should the bill be enacted.

FDA issued its third pediatric priority review voucher in March, which started the clock ticking toward a March 2016 sunset.

Even with the deadline approaching, FDA still has encouraged sponsors to seek the rare pediatric disease designation, which can be a precursor to receiving a voucher ([A#14151022007]).

The news should please industry, which has embraced the program since it was created in the 2012 FDA Safety and Innovation Act as an incentive to encourage development of products for rare pediatric diseases.

The agency has issued six such vouchers so far, the most recent to Alexion Pharmaceuticals Inc. for its lysosomal acid lipase deficiency treatment Kanuma (sebelipase alfa).

It was the company’s second rare pediatric disease PRV ([A#14151208002]).

Several sponsors have been able to sell their vouchers for hundreds of millions of dollars.

AbbVie Inc. purchased a voucher from United Therapeutics Corp. for $350m earlier this year. United received the voucher along with the approval of Unituxin (dinutuximab) for high-risk neuroblastoma ([A#14150819005]).

Will Increases Affect Cures Bill?

Interestingly, the budget authority increase for FDA appears similar to the annual increases that would be promised in the House 21^st Century Cures legislation, and the funding for NIH would be even more generous than reform legislation proposed.

NIH would gain about $2bn in the omnibus bill over its FY 2015 appropriation. The Senate Appropriations Committee said in a statement it would be NIH’s largest increase since FY 2003.

FDA was set to receive $110m and NIH $1.75bn in additional dollars per year for five years in the Cures bill, beginning in FY 2016 ([A#14150706004]).

House Energy and Commerce Committee Chairman Fred Upton, R-Mich., who has been the primary champion of the Cures bill, put out a release on the budget declaring NIH's research boost a "major milestone" in the legislative effort.

“It was important that we got the funding for 21st Century Cures that we were looking for 2016,” said Upton. “We started this conversation two years ago, and working together – with leading stakeholders, doctors, researchers, agencies, and most importantly, patients – we helped shift the debate back to cures and helping folks."

However, the funding increase could also be seen as a blow to Cures' momentum. Creating a boost for NIH made the bill more attractive to many Democrats, and if that's already been accomplished, the remaining provisions may not maintain as much bipartisan appeal as a legislative vehicle.

Given that, interest may shift to the upcoming user fee reauthorization package as the primary vehicle for making desired changes at FDA ([A#14151125004]).

Gene Editing, Fish-Related Riders Included

The additional dollars in the omnibus bill still will come with several policy riders.

FDA would not be allowed to use its funding to propose or implement a rule “allowing or requiring information intended for a prescribing health care professional … to be distributed to such professional electronically (in lieu of paper form)” until a federal law is enacted allowing it.

The provision, targeted at FDA’s electronic labeling rule, was included in the Senate appropriations committee bill earlier this year.

A Government Accountability Office study of electronic labeling found advantages and disadvantages associated with eliminating paper labels Also see "Electronic Labeling Study By GAO Yields “No Consensus,” Avoids Cost Issue" - Pink Sheet, 9 July, 2013..

FDA also would be prohibited from officially receiving requests for exemptions for investigational use of drugs or biologics in research where “a human embryo is intentionally created or modified to include a heritable genetic modification,” according to the bill.

In addition, the bill placated concerns from Sen. Lisa Murkowski, R-Alaska, about genetically engineered fish and the Alaska Pollock.

The bill would specifically define Alaskan Pollock as only those of the fish species harvested in the Alaska state waters or an exclusive economic zone near the state, an issue that had been raised at the confirmation hearing for FDA commissioner Robert Califf ([A#14151117006]).

FDA also would be prohibited from allowing genetically engineered salmon from entering the US market until final guidelines on labeling are issued.

The provisions could help clear the way for Califf's confirmation.

Agency officials approved a genetically engineered salmon product in November. Murkowski decided to block Califf’s nomination over it ([A#14151201002]).

Funding Higher Than Committee Totals

The funding boost appears to be a major win for FDA, which managed an increase over the totals penciled into the appropriations committees' bills in both sides of the Capitol.

Overall, FDA would gain $132.1m more in the omnibus bill than the House proposal and $121.7m more than the Senate proposal.

But the total still is well less than the $4.93bn FDA requested for FY 2016 ([A#14150202005]).

Of the $4.6bn that would be appropriated to FDA, $2.72bn would be budget authority, or non-user fee dollars.

That is between 3.5% and 3.9% higher than the appropriations bills the Senate and House considered, respectively, earlier this year.

The Center for Drug Evaluation and Research would receive nearly $1.4bn, which is about $28.4m more than the House bill and $27.1m more than the Senate bill.

The Center for Biologics Evaluation and Research would receive $354.9m, which is $9.7m more than the House and Senate bills.

An increase is somewhat surprising, especially for the House. Appropriations Committee members told outgoing FDA Commissioner Margaret Hamburg in March that funding was expected to be relatively flat ([A#14150304004]).

Source: FY 2016 omnibus appropriations bill

Priority Review Vouchers, FDA Funding Win In Omnibus Budget Deal

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