Selecting the Next FDA Commissioner—A PhRMA Perspective - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Selecting the Next FDA Commissioner—A PhRMA Perspective
President Obama's choice for agency leadership should take into account several factors.

Pharmaceutical Technology
Volume 33, Issue 1, pp. 122-121

Qualities in a nutshell. Overall, new FDA leadership will be tasked with deftly implementing recently granted authorities, and prioritizing the allocation of bolstered Congressional appropriations and enhanced user fees paid by America's pharmaceutical research and biotechnology companies. The new commissioner will need to work with diverse partners, including researchers, Congress, the White House, patients and pharmaceutical research companies on such measures as the Critical Path Initiative, which improves the scientific bases for product development and manufacture.

Without question, user fees have helped to provide FDA with the essential tools and staffing it needs to protect and promote the public health. However, like Congressional leaders and the White House, PhRMA recognizes the consequences of the agency's insufficient funding. A strong, well-funded FDA is critical to the health and safety of the American public. The incoming FDA commissioner should embrace the need to advocate for an empowered, fully-funded FDA, with a willingness to request additional Congressional resources and authorities, as needed.

The Reagan-Udall Foundation, for example, provides an important place for industry and regulators to work together on mutually beneficial goals such as improving science, streamlining drug approvals, and leveraging industry experience with cutting-edge research tools. While the research foundation has begun its work through private funding, congressional appropriations are needed for it to fulfill its true promise. Through such efforts, FDA and its new commissioner have the potential to follow the lead of the National Institutes of Health, charting the path and leading important public–private partnerships that help patients live longer, healthier, and more productive lives.

Alan Goldhammer, PhD, is vice-president of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA),


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: Pharmaceutical Technology,
Click here