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APPENDIX C

EXPORTS OF PHARMACEUTICAL AND MEDICINAL PRODUCTS to countries that Both (a) Require, in Applications for Market Approval, at Least Some of the safety and effectiveness Data and Information that Section 104 of H.R. 3605 / s. 2748 Mandates FDA Release and (b) Do Not Effectively Recognize Product Patents

1983

(in U.S. dollars)

Country

1983 Dollars

Argentina
Austria
Canada
Chile
Columbia
Finland
Greece
Mexico
Norway
Venezuela
Ecuador
India
Iran
Peru
Poland
Spain
Soviet Union
Yugoslavia
Egypt
Kuwait

$29,598,743

28,534,110 185,762,008

6,425,637 25,627,437

2,831,316 13,346,025 37,227,033

1,656,800 31,322,270 7,948,230 8,895, 291 4,194,037 12,554,083

5,914,782 56,833,053

950, 198 3,989,632 11,974,266 2,504,820

$478,089,771

Source:

EM455, F.T. Exports, Foreign Trade Room
Department of Commerce Main Building
U.S. Bureau of the Census

APPENDIX D

(FDA's "Technical Comments" on the June 2, 1984 Discussion Draft of the Patent Term Restoration/ANDA legislation (retyped verbatim) :)

TECHNICAL COMMENTS ON JUNE 2 DISCUSSION DRAFT
ANDA/PATENT TERM RESTORATION LEGISLATION
Comments are keyed to page and line number of the June 2
draft.

GENERAL COMMENT

1. The June 2 draft fails to include a transition provision. We have pointed out in previous comments that a transition provision is needed to protect the agency from a substantial increase in workload during the first few years immediately following enactment. As currently drafted, the bill would immediately open to ANDA eligibility ali drug products approved from 1962 through 1981 other than those that are subject to patent protection. PDA's analysis of resource requirements associated with a possible post-1962 ANDA procedure established that the immediate eligibility for ANDA approval for drug products approved between 1962 and 1972 would produce unacceptable backlogs of ANDAS (reaching a peak of about 1,300 applications more than 180 days old). However, the agency found that by taking an initial 5-year group, allowing three years for processing, then adding the next 5-year group for a second three year period, it could handle Ehe workload with the addition to staff of only four persons. If the agency were to timely process an initial io year period of applications, its analysis showed that it would need 21 additional ANDA reviewers, and these extra reviewers would need to be relocated after the initial submissions had been processed, because FDA estimated that the increased level of staffing would not be needed beyond the first three years.

To prevent unacceptable backlogs of pending applications and to avoid substantial resource increases that would be needed for only a relatively short period of years, a transition provision should be incorporated in the bill. As we have pointed out, a transition provision that opened only the 1962-67 period to ANDA approvals for the first three years after enactment would alleviate the immediate resource impact of the legislation but would still make immediately available for ANDA approval most of the drugs that would be available under the bill as currently drafted, including six of the drugs that are among the top selling prescription drug products.

ANDA PROVISIONS

2. The definition of the term "therapeutic alternative" has been deleted from the June 2 draft, but the bill still includes the concept (page 3, lines 24-27; page 4, lines 1-3) and the associated petition procedure for combination drugs (page 6, line 24; page 7, line 9). The petition procedure would permit prospective applicants to seek permission to file for ANDA approval of combination drugs that have not been previously approved. These new combinations would be required to include at least one ingredient that is the same as an ingredient in a listed (previously approved) drug. Because ANDA approval would appear to be authorized for a combination of active ingredients that had not been previously approved, the petition procedure and its associated 'therapeutic alternative". concept are plainly. inconsistent with the medical and scientific rationale that supports FDA's current ANDA procedure.

In addition, the petition procedure appears to be inconsistent with FDA'S combination policy, 21 CFR 300.50, which generally requires a showing through appropriate studies comparing the combination with its individual active ingredients that each ingredient contributes to the safety or effectiveness of the combination drug. A number of provisions in the June 2 draft would appear to restrict FDDA to consideration only of the safety and effectivenes of the different active ingredient in the new combination rather than to the new combination as a whole:

ANDAs for new combinations would be required to
include information showing that the different
active ingredient had been previously approved
Tapparently either as a single ingredient or as
part of another combination), or that the different
ingredient was no longer a new drug, and any other
information with respect to the different active
ingredient with respect to which a petition was
Filed as the Secretary may require (page 3, lines
1-8).

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The petitions procedure (page 6, line 24
line 9) requires that a petition for ANDA eligi-
bility for a new combination be approved unless
the secretary finds that investigations are needed
to show the safety or effectiveness of the active
ingredients in the new drug which differ from the
listed drug.

Approval of an ANDA authorized through the petition
procedure may be denied if the ANDA fails to contain
information required by the Secretary respecting the
active ingredient in the new drug which is not the
same as in a previously approved drug Tpage 9, lines
8-11).
Approval of an ANDA authorized through a petition
may be denied if the application fails to show
that the new drug can be expected to have the same
therapeutic effect as the listed drug (page 9, lines

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Under FDA's current policy, approval of combination drugs that have not been previously approved would require dată showing that the new drug (not just one of its ingredients) will have its intended effect. Consistent with the agency's current policy, the abbreviated procedure should be limited to drugs with the same active ingredients. Combinations of drugs with active ingredients different from previously approved drugs should be the subject of investigations to establish whether they are safe and effective.

For these reasons, the petition procedure that would authorize ANDA approval for combination drugs that have not been previously approved should be removed from the bill. The statutory ANDA procedure should be limited to duplicate versions of previously approved drugs under previously approved conditions of use.

3. Page 6, line 24. If a petition procedure consistent with FDA's current policy for ANDA approval and the approval requirements for new combination drugs were to be incorporated in the bill, it should eliminate consideration of ANDAS for drugs with different "active ingredients." The procedure should be limited to minor differences in route of administration, dosage from, or strength. Under FDA'S current ANDA policy, different "active ingredients" as therapeutic alternatives are not permitted. There may be circumstances in which route of amdinistration, dosage form or strength may differ slightly from those for a previously approved drug product. However, it should be stressed that even minor changes would not routinely be subject to implementation through ANDAS without clinical data.

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