By Billy Tauzin, president and CEO, Pharmaceutical Research and Manufacturers of America (PhRMA) - 01/26/09 05:53 PM EST
As a cancer survivor who is alive thanks to the miracles of modern science and medicine, I have lived the faith and hope that patients around the world place in the continued discovery of new, life-saving medicines. A strong Food and Drug Administration is key to keeping that faith alive and to maintaining the United States as the world’s center for new medical discoveries.
From that perspective, I believe it is essential that the new administration quickly appoint a new FDA commissioner capable of guiding a strong, fully funded, modernized agency ready to tackle the scientific challenges of this new century.
Every day the FDA touches the lives of all Americans. One out of every four dollars consumers spend is for an FDA-regulated product. Moreover, the challenges confronting the agency steadily grow.
The FDA must be ready to respond to new threats, including, for example, tougher strains of antibiotic-resistant bacteria and dangerous counterfeit products. International commerce increasingly adds a global dimension to the FDA’s role in inspection and surveillance. The agency is regularly tasked with new drug safety responsibilities, including the implementation of a new electronic system to track post-market adverse reactions to drugs. And, the FDA must make difficult decisions about balancing risks and benefits of ever more complex — but promising — drugs, biologics and devices.
Over the years, the agency’s expert public servants have done a remarkable job as their responsibilities have increased. However, in the last 12 years, the FDA has had a permanent commissioner for a total of only five-and-a-half years.
That’s why I was excited to read that the Obama administration intends to move quickly to appoint a new commissioner. Such a move would be good news for all Americans, but particularly for patients depending on the FDA to provide timely, safe access to innovative medicines that could save their lives.
An agency this critical to the health of Americans and people around the world requires a leader with a unique set of talents. The FDA needs a leader who has experience managing a large, complex organization; who has enough scientific expertise to supervise researchers with an array of specialties; who is resilient and passionate about the agency’s laudable goals; and who commands the respect of employees, the public and Congress in order to successfully advocate for the resources necessary to reach those goals.
A fair, open-minded leader who leaves ideological prejudices at the door will be welcomed. It’s a difficult job, and it will take a special leader to fulfill the demands. But patients, and Americans in general, require no less.
From Mark Strand, president, the Congressional Institute
The Congressional Institute staff and board of directors believe the Jan. 22 article “$25K GOP retreat fee draws fire” contained factual inaccuracies and misconceptions about the institute, its work and its participants. We would like to correct the record.
The Congressional Institute has complied with all legal and ethical obligations in its 23-year existence. It depends on annual voluntary dues and not on “fees.” As a point of fact, board members are not required to pay dues to serve on the board, though many do.
The institute’s supporters, who include lobbyists, do not plan, attend or participate in any session of the annual conference. They are invited to a reception and dinner and depart the next morning. Such a courtesy for a tax-exempt organization’s supporters is commonplace and within ethical rules. All members of Congress who participate in the conference pay their own expenses.
Dues support an extensive and robust program provided by the institute that includes meetings and retreats, policy lunches, bipartisan congressional debates, numerous groundbreaking studies, the nonpartisan House Floor Procedures Manual, a nonpartisan handbook for new staff titled “Surviving Inside Congress,” facilitation of strategic planning sessions, staff training, and briefings for international parliamentarians.
As a nonprofit organization, the institute’s educational mission supports the Congress and helps the public better understand their legislature.