Reuters
The U.S. Food and Drug Administration should make more information public, including its reasons for refusing to approve a drug or device, an agency task force recommended on Wednesday.
If adopted, the changes would shed considerable light on a review process that affects the entire drug and device industries. All of the proposals would offer the public more details on key agency decisions.
Wider disclosure could alter companies' ability to control news that could affect their stock prices, especially negative FDA actions such as denying a product or highlighting safety concerns.
"The FDA would make substantially more information about the regulatory process available to the public" if it accepts the proposals, FDA Deputy Commissioner Joshua Sharfstein and Afia Asamoah, director of the transparency effort, wrote in the New England Journal of Medicine.
Among the recommendations from the FDA Transparency Task Force, which included the FDA's top lawyer, chief scientist and the heads of the drug, device and other centers, was that the agency disclose letters to companies explaining why it declined to approve a product or refused to accept an application.
Such letters, known as "complete response" or "not approvable" and refuse-to-file letters, are currently only released if and when a company decides to make them public.
The agency should also publicly say when a company's proposed drug application has been placed on hold, terminated, or withdrawn, the task force said in a report released on the FDA's website. (Click on: link.reuters.com/dyk25k)
The FDA will take public comments until July 20 on the proposals before deciding whether to adopt them.
FDA Commissioner Margaret Hamburg will make the final decision on which proposals to adopt, Sharfstein told reporters, adding that some actions could come this summer.
Wall Street investors and shareholders have been particularly keen to understand why the FDA rejects products, saying company news releases often give sparse information on why they failed. Companies have said they are concerned about protecting proprietary details about their drugs and devices.
"Investors are frustrated because very often you have companies that like to spin what is in those complete response letters, and there's no way to know what's really in them," said Capitol Street analyst Ipsita Smolinski. Here "there's no question. Everybody has access to the same information."
Representatives for drug and device makers cautioned that the agency must protect their trade secrets.
Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson, in a statement, urged the FDA to "continue to protect proprietary information" and said it would submit more comments directly to the agency.
Disclosing information on products "that are still under review by the agency raises concerns," Advanced Medical Technology Association Vice President Janet Trunzo said.
FDA's Sharfstein and Asamoah said some proposals "would accelerate the development process for medical products by allowing companies to learn from the successes and failures of other products."
The task force also urged FDA to disclose safety and effectiveness summaries from pending applications if there is a public health interest, including when the agency believes it needs to correct misleading information.
Despite the call for more openness, it is unclear how the FDA would disclose the information or how quickly. It is also unclear how much detail could be "blacked out," or redacted, from public view.
"The Task Force believes that trade secrets should remain confidential," the report said.
Consumer advocate Sidney Wolfe said he was concerned that exemption could be too broadly interpreted and that key information could still be withheld.
"There obviously are legitimate trade secrets like manufacturing processes, but safety and efficacy data we don't think should be a trade secret," said Wolfe, head of Public Citizen Health Research Group.
Sharfstein told reporters the agency had not yet looked at whether it had the legal authority or resources to carry out any of the proposals and that it would analyze those issues.
"We didn't want to be sidetracked into a legal discussion," he said, acknowledging that some actions would require a change of law. "We really focused on what's the right thing to do."
If adopted, the changes would shed considerable light on a review process that affects the entire drug and device industries. All of the proposals would offer the public more details on key agency decisions.
Wider disclosure could alter companies' ability to control news that could affect their stock prices, especially negative FDA actions such as denying a product or highlighting safety concerns.
"The FDA would make substantially more information about the regulatory process available to the public" if it accepts the proposals, FDA Deputy Commissioner Joshua Sharfstein and Afia Asamoah, director of the transparency effort, wrote in the New England Journal of Medicine.
Among the recommendations from the FDA Transparency Task Force, which included the FDA's top lawyer, chief scientist and the heads of the drug, device and other centers, was that the agency disclose letters to companies explaining why it declined to approve a product or refused to accept an application.
Such letters, known as "complete response" or "not approvable" and refuse-to-file letters, are currently only released if and when a company decides to make them public.
The agency should also publicly say when a company's proposed drug application has been placed on hold, terminated, or withdrawn, the task force said in a report released on the FDA's website. (Click on: link.reuters.com/dyk25k)
The FDA will take public comments until July 20 on the proposals before deciding whether to adopt them.
FDA Commissioner Margaret Hamburg will make the final decision on which proposals to adopt, Sharfstein told reporters, adding that some actions could come this summer.
Wall Street investors and shareholders have been particularly keen to understand why the FDA rejects products, saying company news releases often give sparse information on why they failed. Companies have said they are concerned about protecting proprietary details about their drugs and devices.
"Investors are frustrated because very often you have companies that like to spin what is in those complete response letters, and there's no way to know what's really in them," said Capitol Street analyst Ipsita Smolinski. Here "there's no question. Everybody has access to the same information."
Representatives for drug and device makers cautioned that the agency must protect their trade secrets.
Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson, in a statement, urged the FDA to "continue to protect proprietary information" and said it would submit more comments directly to the agency.
Disclosing information on products "that are still under review by the agency raises concerns," Advanced Medical Technology Association Vice President Janet Trunzo said.
FDA's Sharfstein and Asamoah said some proposals "would accelerate the development process for medical products by allowing companies to learn from the successes and failures of other products."
The task force also urged FDA to disclose safety and effectiveness summaries from pending applications if there is a public health interest, including when the agency believes it needs to correct misleading information.
Despite the call for more openness, it is unclear how the FDA would disclose the information or how quickly. It is also unclear how much detail could be "blacked out," or redacted, from public view.
"The Task Force believes that trade secrets should remain confidential," the report said.
Consumer advocate Sidney Wolfe said he was concerned that exemption could be too broadly interpreted and that key information could still be withheld.
"There obviously are legitimate trade secrets like manufacturing processes, but safety and efficacy data we don't think should be a trade secret," said Wolfe, head of Public Citizen Health Research Group.
Sharfstein told reporters the agency had not yet looked at whether it had the legal authority or resources to carry out any of the proposals and that it would analyze those issues.
"We didn't want to be sidetracked into a legal discussion," he said, acknowledging that some actions would require a change of law. "We really focused on what's the right thing to do."
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