Execs say FDA should review clinical AND economic value

by | 26th Jan 2015 | News

A new report from PwC claims that over 40% of pharmaceutical and life sciences senior executives support the idea of the US Food and Drug Administration evaluating drugs based on both clinical and economic effectiveness.

A new report from PwC claims that over 40% of pharmaceutical and life sciences senior executives support the idea of the US Food and Drug Administration evaluating drugs based on both clinical and economic effectiveness.

The analysis states that 43% of the 100 senior executives surveyed on issues such as regulations, the development of new therapies, and patient engagement, said they are willing to have their products judged based on both effectiveness and cost. This compares to just 14% in a 2010 poll carried out by PwC’s Health Research Institute.

Some 78% of executives said that the FDA has improved the quality and frequency of its communications in the past two years and 76% think that the agency provides actionable feedback; 70% it offered more applicable guidance, rules and regulations in the past two years.

The PwC report adds that 71% believe that the FDA can accelerate approval programmes by balancing swifter approval with increased post-market surveillance. As to healthcare consumers, the survey found they want input into developing therapies as 39% believe the agency incorporates their views in its review process; only 38% say that drug and device manufacturers adequately consider their views.

Mike Swanick, global pharmaceuticals and life sciences leader, said that “to meet 21st century demands for innovation, it will be important for drug and medical device manufacturers to collaborate with the FDA to consider changes to the regulatory framework”. He added that “while recognising the FDA’s investments to improve its relationships with manufacturers and speed drug and device delivery, manufacturers still want greater flexibility in product development and review”.

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