Humanitarian Device Reform Act of 2011

Humanitarian Device Reform Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to repeal provisions that prohibit the sale of a medical device approved under the humanitarian device exemption (available for devices designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States) for an amount that exceeds the costs of research and development, fabrication, and distribution of the device. Adds provisions clarifying that the 4,000 individuals that must be affected in the United States under the humanitarian device exemption is 4,000 individuals per year so affected.

[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3211 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 3211

     To amend the Federal Food, Drug, and Cosmetic Act to improve 
                    humanitarian device regulation.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 14, 2011

  Mr. Bass of New Hampshire (for himself, Mr. Rogers of Michigan, Mr. 
  Lance, Mrs. Blackburn, Mr. Guthrie, Mr. Paulsen, Mr. Latta, and Mr. 
   Shimkus) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
     To amend the Federal Food, Drug, and Cosmetic Act to improve 
                    humanitarian device regulation.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Humanitarian Device Reform Act of 
2011''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) The humanitarian device exemption (HDE) approval 
        pathway, administered by the Food and Drug Administration 
        (FDA), is intended to accelerate the availability of innovative 
        medical technologies to treat rare diseases or conditions, by 
        allowing sponsors of such devices to demonstrate the safety and 
        probable benefit to patients of medical devices to treat or 
        diagnose a disease or condition that affects fewer than 4,000 
        patients in the United States per year.
            (2) Since the inception of the humanitarian device 
        exemption, only 53 medical devices have been granted an HDE in 
        the United States. From 2005 through 2009, only 20 HDE 
        applications were filed, and a mere 11 were approved by the 
        FDA.
            (3) In sharp contrast, under the Orphan Drug Act (Public 
        Law 97-414) more than 2,150 drugs have been designated by the 
        Secretary of Health and Human Services as being for rare 
        diseases or conditions and 358 such drugs have been approved 
        for use in the United States.
            (4) In 2010, the FDA conceded the scope of the remaining 
        unmet medical needs for American patients, testifying to 
        Congress that ``there are still an estimated 20 million 
        Americans suffering from rare diseases for which there are no 
        approved therapies available''.
            (5) In 2010, the former Director of the FDA's Center for 
        Devices and Radiological Health (CDRH) concluded, ``[t]he 
        potential for HDEs to foster innovation has not been reached 
        because of the regulatory burdens of the program''.
            (6) In 2007, the American Academy of Pediatrics testified 
        to Congress, ``The profit restriction on HDE-approved devices 
        limits the effectiveness of the provision by forcing device 
        manufacturers to only recover their research and development 
        costs''.
            (7) Targeted reforms are consequently needed to strengthen 
        and enhance the HUD/HDE pathway.

SEC. 3. REPEAL OF PROFIT PROHIBITION.

    Section 520(m) of the Federal Food, Drug and Cosmetic Act (21 
U.S.C. 360j(m)) is amended--
            (1) by striking paragraphs (3), (6), (7), and (8); and
            (2) in paragraph (5), by striking ``, if the Secretary has 
        reason to believe that the requirements of paragraph (6) are no 
        longer met,''.

SEC. 4. CLARIFICATION OF REFERENCES TO RARE DISEASES OR CONDITIONS.

    Paragraphs (1) and (2)(A) of section 520(m) of the Federal Food, 
Drug and Cosmetic Act (21 U.S.C. 360j(m)) are amended by inserting 
``per year'' after ``4,000 individuals in the United States''.
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