Inpharma 1551 - 19 Aug 2006

Drug approval process: the statusquo is a no-go

An incentive-based approach could improve the USdrug approval process and encourage drug companiesto optimise current therapies and to develop new drugsfor conditions without effective treatments, according toDr Alastair JJ Wood from the Vanderbilt UniversitySchool of Medicine, Nashville, US.

Dr Wood says that the current drug approval process"rewards duplicative, relatively low-risk drugdevelopment and encourages the use of new, expensive,heavily marketed drugs at the expense of older, equallyeffective drugs of the same pharmacologic class". Hebelieves that incentives, in the form of extendedexclusivity periods for companies’ products, applied tofour particular aspects of the approval process coulddramatically improve this situation.

Firstly, Dr Wood suggests that an extended exclusivityperiod be granted for the completion of long-term safetystudies. Secondly, he recommends that only short-termexclusivity be given initially, with extended exclusivityawarded on the completion of phase IV studies. Next,limited exclusivity could be awarded on the basis ofimaging or a biological markers, but that exclusivitywould only be extended when clinical meaningful endpoint data are confirmed. Fourthly, he recommends theestablishment of a core of high-need conditions forwhich the development of a new drug would result in anextended exclusivity period for the company.

Dr Wood states that "the fundamental goal is toreward true, high-risk innovation that improves medicalcare".Wood AJJ. A proposal for radical changes in the drug-approval process. NewEngland Journal of Medicine 355: 618-623, No. 6, 10 Aug 2006 801035281

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Inpharma 19 Aug 2006 No. 15511173-8324/10/1551-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved