FDA to Release Information Sooner on Pipeline Drugs
FDA to Release Information Sooner on Pipeline Drugs
Following Lawsuit, Agency Posts Advisory Committee Materials on Web
Pharmacists may have a new source of information about drugs in the pipeline following a recent change in FDA policy.
On January 1, FDA started posting advisory committee materials on its Web site (www.fda.gov). The materials, which are submitted by drug manufacturers and agency analysts, are used by committees to decide whether to recommend approval of a drug. They include statistical summaries of safety and effectiveness data, clinical protocols, names of principal investigators, and proposed indications, dosages, and routes of administration. Interested parties have until February 22 to respond to the draft guidance through written comments, but it seems likely FDA will continue the practice.
Before now, the agency did not release such information until the drug was approved, which often was months after the committee meeting. Unless pharmacists and other health care professionals attended the committee hearings in person, they were limited primarily to company press releases for information about drugs being reviewed by the agency. "This gave drug companies time to carve out a market for a drug by selectively publishing favorable information," said Larry Sasich, PharmD, MPH, research analyst at Public Citizen Health Research Group.
FDA Welcomes Participation
The public advocacy group sued FDA last year to make advisory committee material available to the public. Public Citizen hoped the move would allow the health care community to form a more accurate impression of a drug by the time it hits the market. In addition, the organization wanted data on drugs under review so that it could participate meaningfully in committee hearings.
"We couldn't really participate before. That was the absurd thing," Sasich said. "We could attend the meetings and listen to comments on the issues, but we couldn't know what the issues were." He believes his group might have prevented the approval of such drugs as dexfenfluramine (Redux) had it been able to participate fully in the hearing process. Under the new policy, FDA will post committee materials 24 hours before the hearing.
The agency welcomes the involvement. "If you have public advisory committee meetings, the public should be able to participate," Murray F. Lumpkin, MD, deputy director for review management at FDA's Center for Drug Evaluation and Research, told Pharmacy Today. Advisory committees review roughly 40% of new molecular entities submitted to FDA for approval, typically the most novel and innovative drugs.
Trade Secrets
In comments to the agency, the Pharmaceutical Research and Manufacturers of America (PhRMA) will seek to limit the amount of information FDA releases to the public, according to PhRMA Assistant General Counsel Marjorie Powell. The industry trade group believes that the draft guidance inadvertently obliges companies to release trade secrets to competitors.
"We are concerned with the presumption that everything is releasable or should be releasable," Powell said. "We have a quarrel with some specific items." The group, for example, does not think that clinical protocols should be made public. "A company may have developed a method for collecting data that they don't want a competitor to know about," she said.
Commercial confidential information -- including product formulation and manufacturing information -- is exempt from public disclosure under the draft guidance, but exactly what other information the agency considers confidential remains ambiguous.
Public Citizen is likely to oppose PhRMA's efforts. At press time, Sasich was uncertain if his organization would submit its own comments to FDA or wait for the issue to play out in court. The group is suing the agency for access to unpublished trial data on celecoxib (Celebrex). The outcome will have a direct bearing on what is defined as commercial confidential information.
"It will take some time to define where the line is drawn," Lumpkin said.
Following Lawsuit, Agency Posts Advisory Committee Materials on Web
Pharmacists may have a new source of information about drugs in the pipeline following a recent change in FDA policy.
On January 1, FDA started posting advisory committee materials on its Web site (www.fda.gov). The materials, which are submitted by drug manufacturers and agency analysts, are used by committees to decide whether to recommend approval of a drug. They include statistical summaries of safety and effectiveness data, clinical protocols, names of principal investigators, and proposed indications, dosages, and routes of administration. Interested parties have until February 22 to respond to the draft guidance through written comments, but it seems likely FDA will continue the practice.
Before now, the agency did not release such information until the drug was approved, which often was months after the committee meeting. Unless pharmacists and other health care professionals attended the committee hearings in person, they were limited primarily to company press releases for information about drugs being reviewed by the agency. "This gave drug companies time to carve out a market for a drug by selectively publishing favorable information," said Larry Sasich, PharmD, MPH, research analyst at Public Citizen Health Research Group.
FDA Welcomes Participation
The public advocacy group sued FDA last year to make advisory committee material available to the public. Public Citizen hoped the move would allow the health care community to form a more accurate impression of a drug by the time it hits the market. In addition, the organization wanted data on drugs under review so that it could participate meaningfully in committee hearings.
"We couldn't really participate before. That was the absurd thing," Sasich said. "We could attend the meetings and listen to comments on the issues, but we couldn't know what the issues were." He believes his group might have prevented the approval of such drugs as dexfenfluramine (Redux) had it been able to participate fully in the hearing process. Under the new policy, FDA will post committee materials 24 hours before the hearing.
The agency welcomes the involvement. "If you have public advisory committee meetings, the public should be able to participate," Murray F. Lumpkin, MD, deputy director for review management at FDA's Center for Drug Evaluation and Research, told Pharmacy Today. Advisory committees review roughly 40% of new molecular entities submitted to FDA for approval, typically the most novel and innovative drugs.
Trade Secrets
In comments to the agency, the Pharmaceutical Research and Manufacturers of America (PhRMA) will seek to limit the amount of information FDA releases to the public, according to PhRMA Assistant General Counsel Marjorie Powell. The industry trade group believes that the draft guidance inadvertently obliges companies to release trade secrets to competitors.
"We are concerned with the presumption that everything is releasable or should be releasable," Powell said. "We have a quarrel with some specific items." The group, for example, does not think that clinical protocols should be made public. "A company may have developed a method for collecting data that they don't want a competitor to know about," she said.
Commercial confidential information -- including product formulation and manufacturing information -- is exempt from public disclosure under the draft guidance, but exactly what other information the agency considers confidential remains ambiguous.
Public Citizen is likely to oppose PhRMA's efforts. At press time, Sasich was uncertain if his organization would submit its own comments to FDA or wait for the issue to play out in court. The group is suing the agency for access to unpublished trial data on celecoxib (Celebrex). The outcome will have a direct bearing on what is defined as commercial confidential information.
"It will take some time to define where the line is drawn," Lumpkin said.
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