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Counsel are equally mistaken in their apparent belief that once it ringenenl is established and adjudicated, an

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marivices by its language chat once a violation was shown,

an injunction must follos, and the D. C. Circuit had so

held.

But the circumstances made an injunction somewhat

repugnant.

Hecht Co.,

an unquestionably legitimate and

long-established District of Columbia retailer, had got tangled up in the price control regulations of World War ll, and its employees had in good faith unwittingly conmitted some violations. The situation was ironic in that the Hecht Co. had been a leader in extending the patriotic cooperation of the retail trade in application of the unpopular but necessary retail price controls, and had it

self offered its own operation for study as

illustrating

the problems and how they could be solved.

After discovering some loopholes in the statute, in light of the legislative history, Justice Douglas contin

ved at 329:

We are dealing here with the requirements of equity practice with a background of several hundred years of history. Only the other day we stated that "an appeal to the equity jurisdiction conferred on federal district courts is an appeal to the sound discre

tion which guides the determinations of courts of
equity." Meredith v. Winter llaven, 320 U.S. 228,
*235. The historic injunctive process was designed to
deter, not to punish. The essence of equity juris-
diction has been the power of the Chancellor to do
equity and to mould each decree to the necessities of
the particular case. Flexibility rather than rigid-
ity has distinguished it. The qualities of mercy and
practicality have made equity the instrument for nice
adjustment and reconciliation between the public in-
terest and private needs as well as between competing
private claims. We do not believe that such a major
departure from that long tradition as is here pro-
posed should be lightly implied.

While two justices declined to join in the opinion, none expressed themselves in favor of affirming the D. C. Cir

cuit.

In short, if Congress wants the federal courts to

issue injunctions without regard to historic equity principles, it is going to have to say so.in explicit and even shameless language rarely if ever to be expected from a body itself made up very largely of American lawyers, haying, probably, much respect for traditional equity principles as do the courts. If an injunction was not mandatory in Hecht Co. Bowles, the more permissive statutory language here makes it a fortiori that an injunction is not mandatory now.

as

V.

The application of historic equity principles to the at bar' is in the first instance for the district

case

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The decision of the district court holding the '053

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This is in response to a recent request by Mr. Dave Beier of your
Subcommittee staff for information on orphan drugs and approved generic
antibiotics.
Since 1962 approximately 350 generic antibiotic applications have
been approved. Of those 350 approved applications, 150 have been
approved with more than one strength.
With respect to orphan drugs, I am pleased to provide the following
information:

33 requests for orphan drug designations have been received

since October 1983;
- 16 of the designations have been approved (see enclosed list);
- 15 new drug applications (NDA's) for orphan drugs have been

received since January 1983;
- 7 NDA's for orphan drugs have been approved for the following
conditions:

1. Chronic urea-splitting urinary infections.
2. Dissolution of radiolucent gallstones in poor surgical

risk patients.
3. Testicular cancer.
4. Immunosuppressant in organ transplant recipients.
5. Hemophilia A.
6. Hepat ic porphyrias.

7. Severe pain, as in metastatic cancer. If you have any questions, please let me know.

Sincerely yours,

Robert C. We therell, Jr.
Associate Commissioner
for Legislation and Information

Enclosure

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