Friday, May 13, 2011

Where To Find Biosimilar User Fees In Alphabet Soup?

Industry is looking for a PDUFA, but could end up with a FDAAA as it searches for an acronym for the biosimilar user fee to join the lexicon of bureaucratic alphabet soup.

It is an important question, mainly because the series of letters likely will become the most-recognized method of referencing the program. (Of course, how the program might actually run is another important question, one explored in this week's edition of "The Pink Sheet.")

The Prescription Drug User Fee Act is the oldest user fee and PDUFA has long been accepted as a classic acronym.

The 2007 FDA Amendments Act elicited the opposite response. It was criticized shortly after passage for its awkward, A-filled acronym. One person at the time said FDAAA was among the worst acronyms in recorded history.

Many seemed to prefer an alternate title for the bill: the FDA Revitalization Act. It would have shortened to FDARA, a much more pronounceable acronym.

So where would the biosimilar user fee fit in the acronym vernacular? BUFA or BSUFA would continue the “UFA” naming concept.

Shorter acronyms are preferred and the user fee likely will not elicit its own legislation, so maybe the “A” should be dropped. That would leave BUF or BSUF, but both seem awkward-sounding.

Indeed, negotiators for the generic user fees that are expected to be created sometimes refer to that program as GDUF, but it's unclear if they are being serious.

Maybe the biosimilar user fee will require a break from tradition, just like the negotiating process FDA is employing to create the program, and employ no acronym. After all, biosimilars are similar, but not the same, as their reference products.

Patricia Knight, president of Knight Capital Consultants, and a former chief of staff for Sen. Orrin Hatch, R-Utah, one of the principal authors of the legislation, said crafting a title for it “was just horrible.”

“We could get through some of the hardest stuff, but we were stumped on the title,” Knight said May 4 during a conference on the future of biosimilars in the U.S.

“We were throwing out ideas and we decided to pay a tribute to the Drug Price Competition and Patent Term Restoration Act, so it would be parallel to the Biologics Price Competition and Innovation Act. Truth be known, that title was picked in a contest.”

Are you more creative than Congress? Take our poll below to vote for your favorite biosimilar user fee acronym or offer your own.

Derrick Gingery

Photo by Flickr user woody1778a used under Creative Commons license.

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