The Food and Drug Administration wants to dramatically simplify and speed up the application process for access to investigational drugs.
The agency Wednesday introduced new draft guidance (PDF) that includes a new application form for physicians to apply for experimental drugs not yet approved by the FDA under its expanded access program.
Dr. Peter Lurie, the FDA's associate commissioner for public health strategy and analysis, wrote in a blog post that the new application form would streamline the process and cut the amount of time needed to complete an application from the current 100 hours to just 45 minutes.
“The new draft guidance and draft form are the latest examples of FDA's determined effort to minimize unnecessary red tape, increase efficiency and better serve patients in need,” Lurie wrote.
The current application process was designed for manufacturers and not for a physician seeking use for one patient, Lurie noted. The process now calls for “26 separate types of information and seven attachments,” he said.
The updated application guidance responds to concerns that “some physicians who are unfamiliar with how to submit an expanded access request may be confused about what is required and therefore deterred from doing so,” FDA spokeswoman Sandy Walsh said in an e-mail to Modern Healthcare.
The new guidance is expected to be published in the Federal Register this week, where it will be subject to a 60-day public comment period. Walsh could not provide an estimate of when the agency expects to finalize the new form, but said it would do so “as quickly as possible.”
The expanded access, or “compassionate use,” program was established in 2009 to allow patients to get drugs and medical devices that haven't gone through the clinical trials needed before the FDA can approve their sale. The FDA has approved more than 99% of expanded access applications submitted in the last four years and has OK'd a number of submissions in a matter of days, according to Walsh.
But critics argue the FDA process remains lengthy and can take up to several months. Such criticism has led to the passage of so-called “right to try” laws in several states over the past year that allow terminally ill patients to get drugs and medical devices not yet approved by the FDA.
Lawmakers in Arizona, Colorado, Louisiana, Michigan and Missouri have passed similar laws by overwhelming majorities in the past year, with other bills introduced in 24 states.
The FDA “has not taken a position on any state's 'right-to-try' law,” Walsh said.
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