FDA may be wondering whether a lack of praise for its user fee program actually could be a criticism after a survey did not find overwhelmingly agreement the dollars were serving their intended purpose.

The agency is negotiating with industry in preparation for the fifth Prescription Drug User Fee Act cycle, which includes user fees for new drug applications. New fees also are expected for biosimilar and generic drug applications and potentially could be included in the reauthorizing legislation.

But industry confidence in the ability of user fee dollars to produce timely application reviews is not overwhelming, according to the PricewaterhouseCoopers survey of the relationship between industry and FDA, “Improving America’s Health V.”

Only 24% of industry respondents agreed FDA was using user fee dollars as intended and no one strongly agreed with the statement. A total of 26% disagreed or strongly disagreed.

The surprising number was the 40% of respondents who voted neutral on the question, which meant that 66% of respondents were not comfortable enough to indicate the agency was spending user fee money as intended.

Respondents also did not heartily endorse the level of service they are receiving for the money being paid. More people agreed than disagreed, 30% vs. 26%, that user fees were excessive given the levels of FDA staff time that go into the product review process. But the most people again came down neutral, 38%, and another 6% said the question was not applicable.

PwC surmised in the report that the results could mean companies may be willing to pay more if they “could see clear evidence that user fees improve the review process.”

Communication A PDUFA V Theme

Industry has made review times one of its primary issues in this most recent PDUFA round. Not only has it asked FDA to speed up its process, but also to include more mid-cycle communication.

The agency has countered with a plan to automatically extend reviews in some cases in order to improve its first-cycle review record.

In the survey, user fee payers did not feel the funding was working as intended, which is to quicken application review times. Forty-six percent of respondents disagreed that user fees accelerated product review times, while only 32% agreed.

A bold potential change to the review process considered this year would have split it into four phases and allowed FDA to stop the review clock mid-cycle. It was dropped because there were too many questions.

PDUFA talks have returned to including the possibility of a mid-cycle meeting in the existing process (Also see "PDUFA V: FDA Offers Mid-Cycle Review Talks, But Industry Wants Them Later" - Pink Sheet, 6 December, 2010.).

Agency Also Getting Better At Talking

Ironically, communication also was an area where survey respondents saw a lot of improvement (see charts).

Source: PricewaterhouseCoopers: Improving America's Health V

Source: PricewaterhouseCoopers: Improving America's Health V

Communicating with sponsors during the development process was tied as the second-most popular area of improvement at the agency in the last two years, according to the survey. The most popular was providing feedback at the beginning of development. However, no improvement also was the second-most popular choice among respondents.

Source: PricewaterhouseCoopers: Improving America's Health V

Source: PricewaterhouseCoopers: Improving America's Health V

In the coming two years, industry wants to see improvement in turn-around time the most, according to the survey. The second-most sought improvement was providing more guidance during the development process, followed by communicating with sponsors during the development process.

Source: PricewaterhouseCoopers: Improving America's Health V

Source: PricewaterhouseCoopers: Improving America's Health V

(Editor's note: Click here for a printer-friendly version of the charts.)

Support also is mounting for a new limited launch approval process, according to the survey. The “living license” process for applications would allow a limited product launch based on a small amount of data, with expanded marketing allowed as more favorable evidence develops (Also see "FDA Approval Via "Living License" Gaining Backers, But Major Players Not Among Them" - Pink Sheet, 6 December, 2010.).

By Derrick Gingery

Industry Skeptical Of User Fee Success, PricewaterhouseCoopers Finds

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