| FDA Falls Short
by Frank Burroughs
 On Monday, December 11, 2006, the FDA issued for comment its draft regulations
addressing Expanded Access to Investigational Drugs for Treatment Use and
Charging for Investigational Drugs. The draft regulations were a non-event.
In fact, the FDA is admitting in its statements that its policies
allowing access to investigational drugs haven't been working nearly well
enough since by the agency's own admission and in fact, the new regulations merely
clarify their existing policies. All of the supposedly new access
and charging mechanisms the draft regulations lay out have been available for
years from the FDA. But they have fallen far short of meeting the legitimate needs
of patients because they are unworkable in the large majority of
circumstances for drug companies, doctors and patients.
The FDA has also stated in very carefully worded comments in their press
release that they hope letting drug companies (sponsors) and patients know
about the programs will make them work better. Left out, however, is
the fact that sponsors and physicians already do know about the programs. The problem is
patients have no direct ability under the agency's policies to request or receive an
investigational drug.
Access hinges on a drug company's willingness and
ability to provide the drugs outside clinical trials before their drug is
approved. For a variety of reasons, some of which have their roots
in the agency's failure to modernize its drug development and approval policies, the FDA's
access mechanisms are a largely unworkable minefield for drug company sponsors.
The FDA merely staged a public relations event in which they succeeded in
getting many in the media to report misleading statements that change is
underway, when in fact the FDA did the opposite. The policies in the draft
regulations have been available under laws passed by Congress since
as early as 1987, and by going through rulemaking to write these old, largely inoperative
programs into regulation, the FDA is cementing its long-failing policies into
place and making it much harder to modify them.
Changing a regulation requires an agency to again go through rulemaking, a process that can take years.
To put this in perspective, for the thousands of patients who need access to
an investigational drug right now, many of whom (left untreated) won't even
survive the 90 day comment period for these "stay-the-course" draft
regulations, this is a continuation of a long-standing, highly-lethal, regulatory
failure.
The Abigail Alliance for Better Access to Developmental Drugs expresses its
deep disappointment with the FDA's decision to maintain a failing status quo. We have submitted
proposals for real reform in a Citizen's Petition filed with FDA in June 2003 to which the agency
has never responded and have sued the FDA and HHS in July 2003 to move the bureaucracy forward.
Real reform was proposed in the Access Act introduced in the Senate and House by Senator Sam
Brownback (R-KS) and Representative Chris Shays (R- CT). But the FDA continues in its old inefficient ways.
We will continue to pursue real changes on behalf of patients with serious and terminal diseases
and no other options to make legitimate access to investigational drugs a reality.
Frank Burroughs is president of Abigail Alliance for Better Access to Developmental Drugs.
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