submission of full reports of safety and effectiveness studies for generic drug products.

To give you some idea of the impact a post-1962 ANDA system would have, by the end of 1985 there will be approximately 160 drugs approved since 1962 that will have come off patent, and that number will grow by over 30 percent by the year 1990. A number of drugs about to come off patent are also among the nation's top selling prescription products. Of the post-1962 drugs coming off patent by the end of next year, six are among the nation's top ten sellers in terms of retail sales. That number, too, will grow over the next several years.

A post-1962 ANDA procedure would be consistent with a number of FDA programs that have aided the marketing of generic drugs. In addition to the pre-1962 ANDA procedure under the DESI program, FDA has permitted generic applicants for post-1962 drug products to rely on reports of studies published in the open scientific literature, the so-called paper NDA process. However, adequate literature is available for relatively few post-1962 drugs.

For these reasons, the Committee is to be commended for introducing this important legislation.

S. 2748 (Title I)

Let me now turn to the specific bill. We believe that with a few technical modifications S. 2748 would contain the essential ingredients for balancing many complex and competing considerations surrounding an equitable ANDA system. If adopted, these modifications would not upset

the careful balance that S. 2748 is intended to achieve. Our concerns go primarily to the manner in which FDA would be asked to implement the post-1962 ANDA system. To gain the desired benefits, the system needs to be manageable and workable. That is our main concern and I would like to summarize our recommendations for you.

1. The Bill Would Create a Burdensome Backlog of Applications

S. 2748 would immediately open to ANDA eligibility all drug products approved from 1962 through 1982 that are no longer protected by patent. We foresee a difficult period arising from this in which our current review resources could not handle the incoming applications. Within the first six months of enactment we might receive 900 applications, followed by 400 applications during the next six months. Thousands more would follow during the next several years.

Our objective is to deal with these applications in the most

efficient and productive manner possible. To that end, we are already evaluating the resource implications and gearing up, to the extent possible, to implement this legislation. However, Mr. Chairman, you should be aware that we would be unable to act on each application within the 180 day time-frame specified in the bill if we were confronted by the staggering volume of applications that we anticipate receiving.

To remedy this situation, we recommend that the bill establish an orderly phase-in of eligibility for ANDAS. One possibility is to begin with drugs in order of initial approval. Another is to begin with drugs that represent the greatest prescribing volume. In

any event, we would aim to open the process to all drugs in the shortest possible time and we would be pleased to work with the Committee to achieve an equitable and workable solution.

2. Different Active Ingredients Should Not Be Specifically Authorized

Second, we recommend deletion of provisions in S. 2748 that permit ANDAS for new combination drugs. We believe that, as a rule, ANDAs should be limited to drugs which have the same active ingredients as the pioneer drugs. There may be rare instances in which the public interest is served by permitting ANDAs for combinations which have not been previously approved. But overall, we do not believe that it is in the public interest to encourage the proliferation of new combinations without adequate clinical testing for safety and effectiveness.

We would be pleased to work with the Committee to develop a procedure to approve new combinations in those limited circumstances where public health and scientific considerations make such approvals appropriate.

3. Linking Effective Date of Approval to Patent Status of the

Pioneer Drug Has Resource Implications

S. 2748 ties ANDA and paper NDA approval to the patent status of the pioneer drug. The effective date of FDA's approval of an ANDA or paper NDA would vary, depending on whether the pioneer patent had expired or

was still running or whether the patent status of the pioneer was being litigated.

As a result, FDA would be responsible for delaying the effective date of approvals pending resolution of such matters as civil litigation or requests for reexamination of patentability to the Patent Office, and for delaying the effective date of the approval of subsequent generic applications until the first generic drug involved in a patent

challenge had been marketed for 180 days.

Although these provisions are not intended to require judgmental determinations with respect to patent status, the new and complex recordkeeping that would be required would have resource implications for the Agency and would also embroil us in the substance of patent controversies. For example, a successful litigant in a patent suit would learn of a court decision before FDA could be officially notified and, from our experience, would pressure the Agency to issue an approval prior to the official notification, or perhaps simply market the product, leaving us with an enforcement problem.

We understand that the purpose of these provisions is to prevent the marketing of duplicate products before issues concerning the pioneer's patent status are resolved. Mechanisms are available, however, to protect patent rights which need not involve the limited resources of FDA. In our view the requirement in S. 2748 that ANDA and paper NDA applicants must provide notice of their intentions to the patent holder should be adequate to protect the patent status of the pioneer product. This notification, which would precede ANDA or paper NDA approval in every case by six months or more, should enable the pioneer

manufacturer to protect its patent rights through judicial remedies.

4. Veterinary Drugs Should Be Included

S. 2748 would provide patent protection for pioneer veterinary drugs but would not authorize an abbreviated application procedure for generic versions of these products. We believe that veterinary drugs should be included. A post-1962 abbreviated new animal drug application policy would essentially eliminate the need to reprove that which has already been established. The benefits of such a policy would accrue primarily as savings through the increased availability of lower-priced generic animal drug products. Less expensive drugs available to the livestock producer and the veterinarian should result in savings in the cost of food and savings in health care for companion animals.

I would note that the animal drug provisions in Title II are inconsistent with those contained in H.R. 5529, a bill designed to extend patents for both agricultural and chemical products, and that the United States Department of Agriculture has officially notified Congressman Kastenmeyer of its support for the bill. While FDA has not been asked to provide its views on H.R. 5529, we encourage the Congress to review the possibility of reconciling these differences as quickly as possible in order to enact the most meaningful set of legislative changes.

PATENT RESTORATION

Turning now to patent restoration, it is well-known that products requiring FDA premarket approval sometimes entail high development costs, the risk of failure and small potential markets. And as an