For a stronger FDA

RE "AMERICA needs a strong FDA" (Op-ed, Dec. 6): I agree that Congress should make a long-term commitment to increase Food and Drug Administration funding, and that stable leadership is needed at the agency, but I would add two points.

First, increasing the FDA's budget to hire more professional staff is a good first step, but drug and medical device firms should still be responsible for paying some portion of the costs associated with reviewing and approving their new products. Thus, the Prescription Drug User Fee Act and its medical device counterpart may still be needed in some form. The Obama administration will need to strike a balance between federal and private funding for these reforms.

Second, besides impeccable scientific and managerial credentials, the next FDA commissioner should not have any ties to the industries regulated by the agency. To safeguard the nation's health, the commissioner must improve the FDA's performance in monitoring manufacturers' advertising claims, ensuring timely and full disclosure of adverse effects of approved products, and enforcing regulations regarding "off-label" use of approved products.

If Congress insists upon these safeguards and passes legislation that allows Medicare to negotiate discounted drug prices, then Americans are more likely to have better access to safe, effective, and affordable new technologies.

ALAN B. COHEN, Boston
The writer is professor of health policy and management, and executive director of the Boston University Health Policy Institute.