Pharma Adapts to the New Health Economy

A stronger focus by consumers and insurers on cost-effectiveness as well as medical benefit will increase pressures on the FDA to consider similar changes, according to a new report from PwC’s Health Research Institute (HRI).

In “The FDA and industry: a recipe for collaborating in the New Health Economy,” HRI surveyed of senior executives from pharmaceutical and life sciences companies on their views about the industry’s relationship with the FDA.

“While recognizing 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,” Mike Swanick, global pharmaceuticals and life sciences leader, said in a statement.

Drug and device companies are also adapting to a greater consumer and insurer focus on cost-effectiveness. According to HRI, 43% of respondents said they were willing to have their products be judged on both clinical and economic value. In 2010, only 14% said the same.

The report also found that 78% of executives believe the FDA has improved the quality and frequency of its communication in the past 2 years. Respondents also acknowledged that balancing risk and innovation when developing new drugs and devices requires tradeoffs. Accordingly, 71% of executives are willing to consider regulatory reforms, such as stricter post-market safety requirements, in order to accelerate FDA approval programs and improve access to new treatments.

However, patients are not so happy. Only 39% believe the FDA incorporates their views into the review process, and roughly the same amount say drug and device manufacturers adequately consider their views. According to PwC, consumers’ definition of value differs from regulators and the industry, and as such they want a greater voice.

“With greater access to medical information than ever before, consumers are assuming responsibilities that have historically resided with the FDA or industry—such as developing guidance, creating incentive programs, and funding research and development directly,” Michael Mentesana, PwC's US pharmaceutical and life sciences research and development advisory services leader, said. “As a result, companies have a real opportunity to seek out and use consumer feedback to better demonstrate value over existing therapies.”