The DSOB Dives In, But Is It Doomed to Fail?

Amid controversy, FDA’s Drug Safety Oversight Board is already making drugs safer for consumers, says executive director Susan Cummins, M.D.

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By Paul Thomas, Managing Editor

FDA’s new Drug Safety Oversight Board (DSOB) began meeting earlier this year under a veil of secrecy and amid skepticism about whether or not it can do anything to ensure that consumers are kept informed about the potential adverse effects of the drugs they take.

The Board aims to provide health care professionals and patients with up-to-date safety information about important medications — eventually through a Drug Watch Web page. Already, CDER has posted 36 Patient Information Sheets on the Internet for public viewing (www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm).

Critics like PhRMA contend that too much information could play upon consumers’ “irrational fears” and do irreparable damage to the image of valuable drug products.

Pharmaceutical Manufacturing asked the Board’s executive director, Susan Cummins, M.D., MPH, to respond to some of these concerns.



P.M.: How long will it take to get the Drug Watch Web page up and running?

DSOB: The proposed Drug Watch Web Page will not be active until a final guidance is published. FDA made a draft guidance available explaining the proposed Drug Watch Program, and solicited input from the public. The comment period for public input ended on August 8, 2005, and FDA is currently in the process of reviewing the comments that have been received. It is not possible to give a time frame regarding how long this will take.

P.M.: There are concerns that making too much information public about potential drug dangers could lead to unnecessary alarm or confusion. How is the Board addressing this issue?

DSOB: The goal of the proposed Drug Watch Web Page is to make emerging safety information available to healthcare professionals and patients so they can consider the information themselves and make better-informed treatment decisions. The information that will be posted on the proposed Drug Watch Web page is limited to emerging and important safety concerns that may influence physician prescribing, patient use, or the risk benefit analysis of a specific drug.

Posting information on the proposed Drug Watch Web page would not mean that FDA has concluded there is a definitive causal relationship between a drug product and the risks or adverse events described, nor would it mean that FDA is advising practitioners to discontinue prescribing a drug. Furthermore, FDA would not expect companies to stop marketing a product just because information about that product appears on the proposed Drug Watch Web page.

The proposed Drug Watch Web page would provide a single Web page through which FDA could communicate emerging safety information and trends while FDA continued to evaluate that information. All drugs have risks, and patients and their healthcare professionals balance those risks against a drug's benefits when making judgments about an individual patient's therapy.

P.M.: What is the Board doing to ensure appropriate independence from FDA’s drug approval and post-market review?

DSOB: The Board has broad representation from the many offices within CDER that play a role in the evaluation of drug safety concerns. In addition, the Board has an equal number of representatives from the Office of New Drugs and the Office of Pharmacoepidemiology and Statistical Science, including two from its Office of Drug Safety. The other voting members come from technical offices within CDER (such as compliance, pharmacology, and pediatrics) that provide the cross-cutting expertise in aspects of drug safety and are needed for their specific knowledge.

Board members are required to recuse themselves from voting on an issue concerning a specific drug if they have been directly involved in the regulatory decision-making (e.g., signed a regulatory action) concerning that drug. The Center Director, who is not typically involved in the approval of new drugs, will make the final decisions on drug safety issues based on the recommendations of the Board.

Decisions made by the Center Director, based on recommendations made by the Board, will be implemented through the appropriate program office. The Center Director retains final authority for Center decisions. All recommendations of the Board may be appealed to the Center Director by a dissenting Office Director before the Center Director makes a final decision.

P.M.: The Board has been criticized by some for being biased in favor of industry. Is there justification to this?

DSOB: This is simply not true. The Board has been constructed to have balanced and equal membership from the Office of Pharmacoepidemiology and Statistical Science and the Office of New Drugs and is not biased in favor of industry. This is also demonstrated by the number of Healthcare Professional and Patient Information Sheets that have been posted since February 2005.

P.M.: How is the Board working with industry? Was there ever any discussion to involve industry representatives in board proceedings?

DSOB: Board membership is limited to federal employees, and board meetings are closed to the public because the information discussed is pre-decisional and may include confidential commercial information. The role of the Board is to oversee FDA’s internal management of drug safety issues and in this capacity “working with industry” is not appropriate. FDA informs a drug sponsor before information about an important drug safety issue is made public. The review divisions will continue to work with industry, and when necessary will provide information to the Board on emerging safety issues.


IDEA OF DSOB DRAWS MIXED REVIEWS

The announcement of a Drug Safety Oversight Board drew a flurry of skepticism earlier this year. Media heavyweights immediately weighed in. Here’s what a few had to say:

The New York Times (February 17, 2005):
Half a Step on Drug Safety


“If the Board is intended to be the [Bush] administration’s primary solution for the glaring weaknesses that have been revealed in the Food and Drug Administration’s ability to protect patients from adverse effects that show up only after a drug is widely used, it will fall woefully short.

“The most important reform, if it takes place, will be a promised change in attitude at the FDA: from a passive stance, focused on protecting industrial trade secrets, to an aggressive stance, bent on getting information to the public. Once the information is out, doctors and patients can make their own decisions... “

The Washington Post (February 22, 2005):
Board Welcomed, with Trepidation


“With some trepidation, we welcome the Food and Drug Administration’s decision last week to set up an independent Drug Safety Oversight Board, as well as an informational web site. . . The new system strengthens the FDA’s focus on monitoring drugs it has approved, adds outsiders’ perspectives to safety issues and enables the agency to more quickly make public its suspicions about particular drugs.

“Still the FDA’s planned new system contains some potential pitfalls. What status will the agency give to unproven suspicions about drugs, for example? Mere publication of doubts about a drug might persuade millions of people to stop taking it. That in itself could lead to harmful effects. Also, if the FDA posts its view that a particular drug might have unwanted side effects, will other drug companies be able to use that information in their advertising? If so, the public’s perception of the dangers might be unduly magnified.

Detroit News (February 27, 2005): DSOB is the Right Step

“The formation of the board is a better way to monitor medicines than through legislation, which critics of the FDA have proposed. Prescription medicines in America are the most regulated and safest in the world. Neither the FDA nor the government accepts sub-standard safety guidelines, as consumer groups have suggested.

“This panel won’t completely satisfy some who want absolute certainty that the synthetic, man-made drugs they’re ingesting won’t have adverse side effects. What they need to realize, however, is that taking prescription drugs comes with risks, but the benefits normally outweigh them.”

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