In the United States, the relationships and finances exchanged between Industry and researchers have long been making news and point to a bias in which patients are often not the prime concern. Now, says Reuters, potential changes could incorporate transparency, broaden disclosure, and provide the public with a view into the details of critical U.S. […]
In the United States, the relationships and finances exchanged between Industry and researchers have long been making news and point to a bias in which patients are often not the prime concern. Now, says Reuters, potential changes could incorporate transparency, broaden disclosure, and provide the public with a view into the details of critical U.S. Food and Drug Administration (FDA) decisions.
“The FDA would make substantially more information about the regulatory process available to the public” should the proposals be accepted, said FDA Deputy Commissioner Joshua Sharfstein and Afia Asamoah, director of the transparency effort, reported Reuters, citing the New England Journal of Medicine.
The FDA Transparency Task Force—which includes the agency’s leading attorney and scientist as well as the heads of its drug, device, and other centers—recommended that the FDA disclose letters to companies to explain its reasons for declining a product or for refusing to accept an application for a new <"https://www.yourlawyer.com/practice_areas/defective_drugs">drug or device, said Reuters. The letters are known as “complete response” or “not approvable” and refuse-to-file letters, are only released should a company opt to make them public, explained Reuters.
Last year, we wrote that in an effort to improve operations and ease consumer concerns, the FDA announced the creation of the task force to develop recommendations for enhancing the transparency of its operations and decision-making processes. Of note, under the previous administration, the agency was long accused of being corrupt and for a wide variety of issues, conflicts, and failures.
Last year, FDA Commissioner Margaret A. Hamburg, M.D., said that “President Obama has pledged to strengthen our democracy by creating an unprecedented level of openness and public participation in government, and the FDA looks forward to participating in this process…. I have asked the Transparency Task Force to deliver recommendations to me for ways to make more information available and foster better understanding of decision-making.â€
Now, Task Force’s proposals also call for the agency to publicly announce when a company’s planned drug application is “placed on hold, terminated, or withdrawn,†according to a task force report, said Reuters. Public comments will be accepted by the agency until July 20; the final decision on which proposals will be accepted will be made by Hamburg.
Investors are pleased with the plans; however industry has raised concerns. “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,” Smolinski added, quoted Reuters.
Not surprisingly, drug and device makers are concerned about information regarding trade secrets, said Reuters. Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said the FDA should “continue to protect proprietary information,” reported Reuters. Such disclosure, said Advanced Medical Technology Association Vice President Janet Trunzo, on products “that are still under review by the agency raises concerns,” reported Reuters.
“The Task Force believes that trade secrets should remain confidential,” the report said, wrote Reuters. “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, according to Reuters.
