. Woodcock: Predictions for the next 25 years By Maureen Martino...

. Woodcock: Predictions for the next 25 years
By Maureen Martino Comment | Forward | Twitter | Facebook | LinkedIn

Strained government budgets and slow economic growth already have hit drugmakers in the pocketbook, and that pain isn't going to stop soon, FDA's Janet Woodcock said Sunday at the 25th annual AAPS meeting in Washington, D.C. Nor does she expect her agency to escape the suffering.
Calling the worldwide economic crisis "the macro trend of all macro trends," the CDER director said she expects to see decreased staffing and resources due to government-wide cuts--although she hopes her agency won't be hit as hard as others.
The economy was just one of the game-changing trends Woodcock expects to affect biopharma over the next 25 years. In honor of the organization's 25th anniversary, Woodcock, who's been with the FDA since 1986, reflected on the industry's past and offered some predictions for the future.
Another important trend, Woodcock said, is the globalization of drug manufacturing and marketing. Emerging markets have become a major target for the industry, and that growth will prompt changes in oversight, she said. In 25 years, the U.S., EU and Japan will likely become members of a larger group of regulators dedicated to enforcing worldwide standards of drug efficacy and safety. "I think we have to move toward ... international standards in the future," she said. "We can choose to drive toward worldwide harmonization, particularly in manufacturing." Failing to do so will result in regional rivalries and varying expectations from country to country--a system that she believes no country or firm could sustain.
Other changes Woodcock predicted include an overhaul of drugmaking processes to incorporate continuous manufacturing, a revolution in molecular medicine, and, unfortunately, increasingly politicized decision-making on drug approvals and regulation. But at the same time, Woodcock predicted drug regulation will be less intrusive and less complex 25 years from now, thanks to decreasing uncertainty in testing and manufacturing.