WASHINGTON -- The following is a summary of the changesthat will be instituted by the Food and Drug Administration tospeed up drug approvals. The first three reforms, whichincrease the number of people involved in drug approvals, areintended to reduce the backlog of drug reviews at the agency.
Outside experts will be contracted to conduct clinical reviewsfor drugs where the backlog is greatest -- most likelyallergy/pulmonary, analgesics, anti-inflammatory, and anti-infection treatments. The FDA will base its final approval onthese reviews. Drug sponsors have the option of beingreviewed by the agency rather than by a contractor.
In the next 16 months, the FDA plans to certify three or morecontractors to review eight to 12 new drug applications (NDAs).By February 1993, the FDA will evaluate this approach andprepare to expand the number of contractors.
Expanded Use of FDA Advisory Committees
The committees will monitor NDAs and advise sponsors aboutthe design and number of clinical studies needed forinvestigational new drugs (INDs). The number of drugapprovals using advisory committees will double by 1993.
Expanded role for institutional review boards
The FDA will permit sponsors to submit INDs to institutionalreview boards -- bodies that oversee guidelines for humanexperimentation in hospitals -- and accept IRB authorization tobegin trials in human subjects.
Accelerated Approval Process
The FDA will assign an NDA to one of two categories: "routine"or "expedited." Within the categories, review priority will bebased on the principle of "first in, first reviewed."
The FDA will create an accelerated approval process fortherapies that treat life-threatening, very serious or severelydebilitating conditions, regardless of whether a satisfactoryalternative therapy exists, as well as for any condition,regardless of severity, for which there is no alternative.
For accelerated approvals, the FDA will attempt to interpretefficacy standards so that chances for approval are maximized,including allowing the use of surrogate markers in clinicalstudies.
For accelerated approvals, the FDA will move up the approvalpoint, eliminating many requirements for preapproval testingin Phase II trials. Sponsors will be allowed to negotiate withthe FDA to obtain certain data from post-marketing studiesnow required in Phase III clinical trials.
U.S. Recognition of Foreign Approvals
The United States will develop with modern industrializedcountries common standards for clinical trials, submission ofdrug approval applications, requirements for animal testing,good manufacturing practices, plant inspections and so on.
Improved Management of FDA
All newly hired staff will be dedicated to drug approval,particularly in the biotechnology area, until the goals forreducing drug development and approval times are met.
The FDA will develop a plan to fully computerize new drugreviews that includes an implementation schedule, uniformformat for submission of NDAs and product license applications,and information management systems for reviewing andtracking applications. The first phase is to be implemented in1992-93. The FDA expects to receive gifts from industry tohelp pay for this computerization.
The Bush administration will support Senate Bill 640, the"Product Liability Fairness Act," which would exemptmanufacturers from punitive damages when a drug has FDAapproval. -- Kris Herbst
(c) 1997 American Health Consultants. All rights reserved.