FDA seeks wider access to experimental drugs
experimental drugs if a planned regulatory overhaul by the Food and
Drug Administration (FDA) goes ahead.
This week the agency proposed significant regulatory changes to make unapproved drugs more widely and easily available to seriously ill patients who have no other treatment options.
The agency's aim is to modernise the applicable regulations to include all circumstances under which access to experimental drugs is permitted.
The FDA has allowed many types of access to experimental therapies since the 1970's, however, the current regulations governing this deter many drug firms from making these experimental treatments available as they are inadequate and explicitly only recognise emergency use for individual patients and widespread treatment use access for large groups of patients.
Under the proposed new rules, expanded access for experimental drugs would be available to individual patients, small patient groups, and larger populations under a treatment plan when there is no satisfactory alternative therapy to diagnose, monitor or treat the disease or condition.
"FDA believes it is important that its regulations clearly reflect the full range of treatment use programs available to ensure broad and equitable access to experimental drugs for treatment use," said a statement by the organisation.
"By clarifying and streamlining the processes, FDA hopes to encourage companies to make such drugs available, and reduce barriers for healthcare practitioners in obtaining them," said Dr. Janet Woodcock, FDA's deputy commissioner for operations.
In addition the FDA is also seeking to clarify the circumstances and the costs for which a manufacturer can charge for an experimental drug.
"The regulations covering when it is appropriate to charge for an experimental drug need revisions because they fail to account for the full range of circumstances in which charging should be permissible," said the FDA.
"They have also proven difficult to interpret in practice, resulting in confusion over what costs could be recovered."
The proposed rules are open for comment for 90 days and can be found here. http://www.fda.gov/cder/regulatory/applications/IND_PR.htm
The FDA has faced criticism this year over its outdated approach to many regulatory issues and has been actively trying to improve its methodology in several areas.
In September, the agency issued a new draft guidance to help the industry wade through the potential minefield of conducting clinical research on patients without informed consent, in cases of emergencies.
The emergency research regulations, under 21 CFR 50.24, first became effective in November 1996, however this was the FDA's first guidance on the matter, issued after an identified need to assist sponsors, institutional review boards (IRBs) and clinical investigators in interpreting and complying with these regulations.
In July the FDA also announced a series of new policy and regulatory developments to modernise the way it monitors clinical trials and bioresearch.
