PhRMA and FDA object to drug safety bill

An industry representative and a top official from the FDA warned lawmakers on 12 June that proposed drug safety measures could have unwanted side-effects.

The Senate passed a bill in May 2007 that aims to improve drug safety by giving the FDA more legal authority, and this week the House is taking up legislation that is similar but takes an even tougher stance. The fine points of the two bills would need to be reconciled before the reforms could be signed into law.

Speaking during a hearing held by the Health Subcommittee of the House Energy and Commerce Committee, Pharmaceutical Research and Manufacturers of America senior vice-president, Caroline Loew, expressed deep concern about the broad scope of the House's proposed legislation, which she said would create "burdensome, bureaucratic processes for routine risk-management measures".

As an example, Loew noted that under the legislation, if a company wanted to communicate information to healthcare professionals through a "Dear Doctor" letter, it would have to submit a full assessment and proposal to the FDA, and the agency would then have to conduct a formal review and issue a written report. "Clearly, this type of bureaucratic process is not necessary for routine risk-minimisation measures and could have the perverse effect of delaying the communication of important safety information," added Loew.

Loew also objected to provisions that would require companies to submit a marketing plan for any drug being considered for approval by the FDA. "This unprecedented requirement is ill-defined and ill-advised," she said. "It is inappropriate for FDA to review a company's internal competitive plans except in the most extraordinary of circumstances."

And, among other concerns, she argued that the legislation would give the FDA such broad authority for requiring post-marketing studies that it could result in "mandatory post-marketing commitments for virtually all drugsÖwhich in many cases would likely be unnecessary and a diversion of both FDA and company resources from more important activities."

Randall Lutter, FDA's deputy commissioner for policy, also took issue with the scope of the legislation. "While we want to add requirements when the science of drug safety validates their need, we want to avoid changes that will limit access to new medicines and slow down innovations while doing little to address drug safety," he said.

Lutter said that the FDA is concerned about a number of provisions, particularly a "Risk Evaluation and Mitigation Strategy" that would require routine active surveillance and periodic reassessment for all marketed drugs. The proposal is "unnecessarily burdensome" and would duplicate a number of drug safety measures already in effect at the FDA, he maintained.

A better approach would be to put more focus on a public-private partnership to create an active drug surveillance system, Lutter said. In addition, he said the FDA needs additional funding to improve its information technology infrastructure for drug reviews, with the goal of making the drug-safety system entirely electronic.

Other speakers at the hearing included Richard Gorman, chair of the American Academy of Paediatrics Section on Clinical Pharmacology and Therapeutics; Diana Zuckerman, president of the National Research Center for Women & Families; Steve Walker, co-founder of the Abigail Alliance for Better Access to Developmental Drugs; and James Guest, president and CEO of the Consumers Union.