The US Food and Drug Administration (FDA) and the brand-name drug industry have reportedly agreed a new five-year plan which would raise the user fees paid by industry to the FDA for prescription drug approvals by around 6%.
Following lengthy negotiations with the industry, the FDA has published a draft letter setting out its performance goals and procedures related to reauthorisation of the Prescription Drug Fee User Act (PDUFA) to FY2017. The current version of PDUFA expires on September 30 and must be reauthorised by Congress before that date.
If the proposed new Act, known as PDUFA-V, passes in its current form, it would add $40.4 million to the agency's revenues from user fees in FY2012, bringing the total for FY2013 to $712.8 million.
The FDA's draft letter, which is now out for public comment, would increase both the agency's 10-month deadline for reviewing new drugs and its six-month deadline for priority reviews by 60 days. It would also establish an enhanced review model for New Molecular Entities (NMEs), aiming to complete efficiency and safety assessments within the first review cycle, with increased scientific communication and transparency between drug sponsors and agency officials before and during the review process.
The draft also included proposals for greater standardisation and earlier consideration of risk evaluation and mitigations strategies (REMS) in the review process, enhancing agency programmes for post-marketing surveillance and adverse events tracking, and making new resources available to modernise regulatory science and enable the FDA to conduct outreach to patients, in order to better understand their views on disease severity and unmet medical need.
"We're starting to see a lot of innovative therapies come through as a result of all investments in science over the last 30 years," commented Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER). "So this agreement will continue the review programme that allows those products to move expeditiously through the regulatory process so they can reach the public in a timely way," she said.
The Pharmaceutical Research and Manufacturers of America (PhRMA) commented that the agency’s performance goals letter is the result of lengthy technical negotiations between the biopharmaceutical industry and the FDA and also includes "unprecedented input from other stakeholders, including patient and medical provider groups."
"If implemented as published, the PDUFA-V agreement will provide the FDA with much-needed resources and management tools to support patient safety and to promote innovation through increased transparency, predictability and efficiency in FDA's science-based human drug review programme," said David Wheadon, senior vice president for scientific and regulatory affairs at PhRMA.
The Biotechnology Industry Organisation (BIO) said that what has been agreed is "a set of enhancements that seek to restore FDA's review performance and get back to basic for patients."
BIO chief executive Jim Greenwood said the industry has "reinforced its commitment to a well-funded drug and biologics programme that supports sound, science-based regulation consistent with FDA's public health mission," but also pointed out that user fees are intended to support "limited FDA activities around the drug review process and were never intended to supplant a sound base of appropriations."
"We urge Congress to support FDA's mission and fund the agency at the Administration's FY2012 requested levels," he said.
- since PDUFA was first enacted in 1992, Congress has granted it three five-year extensions, the last being in 2007. Last year, branded drugmakers provided the FDA with $573 million in user fees, or around 62% of the approximately $930 million spent each year by the agency to review prescription drugs, up from around 49% 10 years ago.
It is also reported that the FDA and generic drugmakers have reached a compromise agreement for the industry to pay the agency user fees for the first time. The industry's bill for the first year is expected to be around $299 million.