« iepriekšējāTurpināt »
This is in response to an August 3, 1984, telephone request by
Antibody to HBsAg
Blood Grouping Serun -
Humulin R (insulin)
with respect to veterinary drugs there are currently twelve
To summarize briefly, our testimony raised two major concerns with respect to Title II as drafted. First, we noted that having to determine the regulatory review period for each product for which patent term extension was sought would be burdensome to FDA, and urged that instead the applicant be required to determine the regulatory review period for purposes of the patent term extension, subject to discretionary review by this Department. Second, we also recommended that the provisions for determination of due diligence be deleted, such determination would require additional Departmental resources for no net public benefit, since we believe the overwhelming majority of applicants have in fact exercised due diligence.
We would be pleased to work with your staff to address the concerns we have with H.R. 3605.
hthia C. Root
I am pleased to have this opportunity to discuss our views on S. 2748, the "Drug Price Competition and Patent Term Restoration Act," and on draft legislation on the export of in approved drugs.
S. 2748 would revise the procedures for new drug applications by authorizing an abbreviated procedure for generic versions of "pioneer" drugs approved after 1962. It would also authorize the restoration of
patent time lost due to the premarket requirements of the Federal Food,
Drug, and Cosmetic (FDC) Act for drugs, medical devices, food additives
and color additives.
As you know, Mr. Chaiman, these concepts of an abbreviated approval
process for drugs approved after 1962 and patent term restoration are
initiatives given high or iority by this Administration. We fimply
believe that establishing an abbreviated new drug application (ANDA)
system is a public health objective whose time has come.
As more and
more drugs from the post-1962 era come off patent, an ANDA system for
these drugs would increase competition, lower drug costs and save
Amer ic an consumers literally hundreds of millions of dollars in the years ahead. And, by preserving incentives for drug development, the companion provision for patent term extension is also in the public
interest. Accordingly, we support the concepts in S. 2748 and believe
that, with certain technical revisions, the bill would represent a
major advance in our nation's health care system.
Let me prolide some additional background before I turn to the bill
An ANDA is an abbreviated new drug application for marketing approval for a duplicate version of a drug product that has been approved as safe and effective. An ANDA does not contain the clinical data on
human safety and efficacy that were required in the new drug application (NDA) to market the previously approved or "pioneer" drug. It is predicated on the view that the safety and effectiveness of the
ther apeutic entity have been estab 11 shed.
To require repetition of the costly studies originally needed to
establish safety and effectiveness has the effect of barring the
introduction of most generic equivalents. Without an ANDA procedure, the requirement for NDAS has the effect of a secondary patent which
protects the pioneer indefinitely from generic competition. Moreover, a requirement for duplicative clinical studies is scientifically
The Food and Drug Administration (FDA) has long recognized the value
of an ANDA system. ANDAs have been used by FDA under the Drug Efficacy
Study Implementation (DESI) program for the approval of gener ic verstons of drugs first approved only for safety between 1938 and 1962, the year in which congress amended the FDC Act to require that drugs be
shown to be effective as well as safe. A similar procedure has not
been established for post-1962 drugs. In recent years, however, the patents have expired for many post-1962 drugs. As a result, generic
drug manufacturers have become increasingly interested in changing
FDA's drug approval system to eliminate the current requirement for the