New FDA guidance offers risks/rewards for industry

January 20, 2009 – 3:15 pm by Steven Niles

Earlier this month, FDA issued a final guidance on Good Reprint Practices, which will make it easier for pharmaceutical companies to advise doctors on unapproved uses of medicines.  The guidance sets out FDA’s new thinking when it comes to the distribution of medical journal articles and scientific or medical reference publications that discuss unapproved new uses for approved drugs and medical devices marketed in the United States to healthcare professionals. However, these guidelines could also pose new challenges and hidden costs for companies, according to experts at the technology and management consulting company BearingPoint.

Until now,  FDA’s strict requirements forced approval delays for many drugs, BearingPoint experts say. While the new guidelines will allow pharmaceutical companies to provide doctors with medical information prior to what can be a lengthy process for securing FDA approval, it also means the information they provide doctors must be developed quickly, without interfering with drug availability or compromising safety. Therefore, developing plans to ensure safe use of high risk drugs will be critical for the industry in 2009. According to BearingPoint, with the new guidelines in place, there will be increased attention paid to developing Risk Minimization and Mitigation Action Plans to reduce risk without interfering with drug availability or with the delivery of product benefits to patients.

RiskMAPs pose their own challenges to organizations, such as high costs and data management and compliance issues. BearingPoint experts believe that by studying existing REMS and RiskMAPs to identify those elements that have earned FDA approval will help companies develop the right mix of strategy and tactics for their own submissions. They point to programs such as iPLEDGE for isotretinoin products or STEPS for Thalidomid as good examples that can offer clues on how to succeed.

BearingPoint works with pharma companies worldwide to improve the efficiency of their RiskMAPs.  Experts from the consulting firm will share additional thoughts on this topic in our March issue of Med Ad News.

Tags: BearingPoint, FDA, guidance