The U.S. Food and Drug Administration on Wednesday released a drastically streamlined application for access to drugs still in testing.
The move could have implications for a “Right to Try” bill in the Kansas Legislature that says terminally ill Kansans may access those drugs without applying to the FDA.
Proponents of the bill say that the current FDA application process can take more than 100 hours for a physician to complete, which makes it difficult to find doctors willing to do so.
In a post Wednesday on the FDA Voices website, Peter Lurie, the agency’s associate commissioner for public health strategy and analysis, said the new application should take 45 minutes.
“We know why patients want access to these drugs, and we know how busy their treating physicians can be,” Lurie wrote. “So we streamlined the new draft form to be shorter and simpler for physicians to fill out. The new draft form, when finalized, will require only eight elements of information and a single attachment.”
The new applicationis two pages long. It asks for the patient’s initials and clinical history, the proposed treatment plan for the drug requested, a letter of authorization from the drug manufacturer and information about the applying physician, including his or her educational and professional credentials.
The FDA also proposed adding an “emergency” application process that can be done over the phone by a physician and an agency representative.
The FDA has provided an “expanded access” program for people with serious or terminal illnesses to obtain investigational drugs since 2010. Use of the program jumped last year to 1,873 people — a record high. The agency has accepted all but 33 of the 5,995 applications submitted in the program’s history.
The new application has been submitted for public comment but is not final.
Meanwhile, Kansas’ Right to Try Act remains in the House Health and Human Services Committee, where it awaits a vote after a hearing last week.
Rep. Brett Hildabrand, one of a trio of conservative Republicans who co-sponsored it, said he applauds the FDA effort to streamline the application process but will continue pushing the state legislation to circumvent the process.
“I obviously still want to see us progress here in Kansas and look into how the two methods can match up,” Hildabrand said.
Rep. John Wilson, a Democrat from Lawrence, said he wanted to look into the FDA changes, which might make it prudent to wait before voting on HB 2004.
“(I) generally feel that if the FDA is speeding up an existing process that essentially accomplishes the same goal of Right to Try, then I think we should hold off on Right to Try,” he said. “At least until next session.”
Andy Marso is a reporter for KHI News Service in Topeka, a partner in the Heartland Health Monitor team.
