[Federal Register Volume 79, Number 141 (Wednesday, July 23, 2014)]
[Notices]
[Pages 42801-42802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17409]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Availability of Interpretive Rule: Implementation of the
Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B
Program
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice.
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SUMMARY: HHS is announcing the availability of an interpretive rule
providing HHS's interpretation of section 340B(e) of the Public Health
Service Act (PHSA), entitled ``Implementation of the Exclusion of
Orphan Drugs for Certain Covered Entities Under the 340B Program.'' The
interpretive rule states that section 340B(e) of the PHSA excludes
drugs with an orphan designation only when those drugs are transferred,
prescribed, sold, or otherwise used for the rare condition or disease
for which the drug was designated under section 526 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Effective July 23, 2014.
ADDRESSES: Submit written requests for single copies of the
interpretive rule to the Office of Pharmacy Affairs, Healthcare Systems
Bureau, HRSA, 5600 Fishers Lane, Room 8W03A, Rockville, MD 20857. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the interpretive rule.
FOR FURTHER INFORMATION CONTACT: CDR Krista Pedley, Director, Office of
Pharmacy Affairs, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane,
Room 8W03A, Rockville, MD 20857, or by telephone at (301) 594-4353.
SUPPLEMENTARY INFORMATION:
I. Background
HHS is announcing the availability of an interpretive rule entitled
``Implementation of the Exclusion of Orphan Drugs for Certain Covered
Entities Under the 340B Program.'' This interpretive rule explains how
HHS interprets section 340B(e) of the PHSA. 42 U.S.C. 256b(e). This
interpretive rule intends to: (1) Provide clarity in the marketplace;
(2) maintain the 340B Program savings for newly-eligible entities; and
(3) protect the financial incentives for manufacturing orphan drugs
designated for a rare disease or condition, as indicated in the Patient
Protection and Affordable Care Act (``Affordable Care Act'') (Pub. L.
111-148) and intended by Congress.
Earlier this year, after notice and comment rulemaking, HHS issued
a final rule on this subject, ``Exclusion of Orphan Drugs for Certain
Covered Entities Under 340B Program'' (78 FR 44016, July 23, 2013) (the
``Rule''). The Rule was vacated by U.S. District Court for the District
of Columbia on May 23, 2014, on the grounds that HHS does not have the
authority to issue the Rule as a substantive rule. PhRMA v. HHS, No.
13-01501 (D.D.C. May 23, 2014). However, the decision did not
invalidate HHS's interpretation of the orphan drug exclusion in the
Rule.
[[Page 42802]]
Because there still is a need for HHS to clarify its interpretation
of how the orphan drug exclusion in the 340B Program should be
implemented to be consistent with section 340B(e) of the PHSA, HHS is
making available an interpretive rule on this topic. In short, this
interpretive rule clarifies that HHS interprets section 340B(e) of the
PHSA as excluding drugs with an orphan designation only when those
drugs are transferred, prescribed, sold, or otherwise used for the rare
condition or disease for which the drug was designated under section
526 of the FD&C Act. This section of the PHSA does not exclude drugs
that are transferred, prescribed, sold, or otherwise used for
conditions or diseases other than for which the drug was designated
under section 526 of the FD&C Act.
II. Electronic Access
Persons with access to the Internet may obtain the document at
www.hrsa.gov/opa/programrequirements/interpretiverule/.
Dated: July 16, 2014.
Mary K. Wakefield,
Administrator, Health Resources and Services Administration.
Dated: July 18, 2014.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2014-17409 Filed 7-21-14; 11:15 am]
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