Recent problems at FDA can be attributed to the lack of consistent, long-term leadership; insufficient resources; and not enough authority to address safety issues, according to four former FDA commissioners who participated Wednesday in a panel discussion at the George Washington University School of Public Health and Health Services, the Newark Star-Ledger reports.
David Kessler, who served as commissioner from 1990 to 1997, criticized the pharmaceutical industry's use of mass-marketing techniques and direct-to-consumer advertising. "The notion that you can come up with a new drug and millions and millions of people take it safely -- the blockbuster -- that is what got us in trouble," Kessler said.
He believes limits should be placed on DTC advertising for prescription medications. Other former officials participating in the panel discussion were Donald Kennedy, commissioner from 1977 to 1979; Frank Young, commissioner from 1984 to 1989; and Jane Henney, commissioner from 1999 to 2001. Young said that FDA's lack of sufficient funding prevents the agency from properly monitoring post-approval drugs. Henney said FDA needs greater authority to order -- rather than negotiate -- label changes and recalls for drugs that appear less safe than initially thought.
Young said, "FDA needs to be a high priority for the administration and the Congress, and the administration must avoid political meddling." In a separate conference held on Wednesday by the Center for Medicine and the Public Interest, current FDA Commissioner Andrew von Eschenbach said that trust in FDA can be regained through "honesty, openness, transparency and a recognition of vulnerabilities," and he also said that "science" will be the foundation for all agency decisions (Cohen, Newark Star-Ledger, 2/22).
via Medical News Today