Healthy Skepticism Library item: 17610

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Richwine L
US groups urge drug safety steps with industry fees
Reuters 2010 Apr 12
http://www.reuters.com/article/idUSN0913305520100412

Abstract:

• FDA, drugmakers to negotiate new review fees

• Consumer groups press for quicker ad reviews

• Drugmakers seek more efficient process

Full text:

Consumer and patient groups urged U.S. drug regulators on Monday to push for timely advertising reviews, clearer drug labels and other safety measures as they negotiate new fees with manufacturers.

The Food and Drug Administration is gathering input before it starts private talks with drugmakers on the renewal of industry fees that help speed reviews of new medicines. The current fees expire in September 2012.

At a public meeting, consumer groups urged the FDA to use the opportunity to press for other measures to improve the safety and promotion of prescription drugs.

Many suggested the agency seek fees from drugmakers to hire more staff to review television, magazine and online ads aimed at consumers.

“By the time FDA determines an ad is misleading, it has already been seen by thousands if not millions. That has to change. We need user fees the FDA can use to review ads in a timely manner,” said Diana Zuckerman, president of the National Research Center for Women & Families.

Ideally the FDA would review ads before they run, she said.

Drugmakers supported an earlier program to voluntarily pay fees to have their ads reviewed, but Congress failed to provide funding to run that effort.

William Vaughan, health policy analyst at Consumers Union, urged the FDA to require that new medicines be tested against approved treatments rather than a placebo.

“It’s past time to transition to a new system in which drugs and devices are tested against the currently approved best practice,” he said.

Vaughan also urged clearer drug labels with a “fact box” that lists risks and benefits and an FDA effort to address unapproved uses of medicines.

The industry fees total hundreds of millions of dollars each year and have dramatically cut product review times by enabling the FDA to hire more staff. The money supplements taxpayer funds approved by Congress. Consumer groups have criticized the collection of industry fees as a conflict of interest for the FDA, but they said Monday they realized Congress was unlikely to provide enough funding on its own.

Drugmakers called for an extension of the fees but a more efficient review process. In recent years, FDA staff have missed various deadlines to rule on new drugs.

The addition of new measures such as plans to minimize side effects has “led to a breakdown in FDA’s review process” and “eroded some of the positive progress derived from earlier” fee programs, said Dr. David Wheadon, a senior vice president at the Pharmaceutical Research and Manufacturers of America.

“New, more efficient systems and processes are required to address this breakdown in order to deliver safe and effective new medicines to patients without unnecessary delays,” Wheadon said.

“More transparent, science-based standards for benefit-risk assessments and drug approvals are needed,” he added.

The FDA and drugmakers will start negotiating new fees beginning in June with the goal of finishing by January, said Dr. Janet Woodcock, head of the FDA’s drug division. A public review of the proposal is set for September to November 2011.

The agency hopes to send a final proposal to Congress in early 2012. Congress must approve the fees and could add other measures on drug safety, advertising or other issues.