House Hearing on FDA Approval of Medical Devices

At a House Energy and Commerce Committee hearing on the FDA approval process for medical devices, Republican members expressed concerns that the FDA process is slower than in Europe and inconsistent.  However, Rep. Henry Waxman said the FDA process remains the gold standard.  An agency spokesman said the FDA could use more funding in order to have a sufficient number of staff to perform their duties.  Chairman Cliff Stearns said that the problems at the FDA are not a matter of funding.

Senate Judiciary Committee Passes "Pay for Delay" Prohibition

On a 10-8 vote, the Senate Judiciary Committee approved S. 27, Senator Herb Kohl’s legislation that would make illegal any “pay for delay” settlements that allow brand name drug companies from paying generic drug companies to delay a generic drug’s entry into the market.  Senator Orrin Hatch said that the bill would create expensive delays, discourage innovation and hurt the very people it was intended to help.  The Chairman of the FTC praised the bill.

Guidelines for Mobile Medical Apps

The FDA released proposed guidelines under which certain mobile medical applications that pose risks to patients would be regulated.  Apps that would have to meet the new guidelines include: accessories to devices that the FDA already regulates; apps that turn a mobile communications platform into a medical device; and apps that offer suggestions about a patient’s diagnosis or treatment.  Comments are due by October 19th.

Recently Introduced Health Legislation

H.R. 2557 (TICK-BORNE DISEASES), to provide for the establishment of the Tick-Borne Diseases Advisory Committee; SMITH of New Jersey; to the Committee on Energy and Commerce, July 15.

H.R. 2558 (HOSPITALS), to modify the definition of children’s hospital for purposes of making payments to children’s hospitals that operate graduate medical education programs; CICILLINE; to the Committee on Energy and Commerce, July 15.

S. 1376 (MEDICAID), to conform income calculations for purposes of eligibility for the refundable credit for coverage under a qualified health plan and for Medicaid to existing federal low-income assistance programs; ENZI; to the Committee on Finance, July 18.

S. 1378 (MEDICAID), to ensure that Social Security and Tier 1 Railroad Retirement benefits are properly taken into account for purposes of determining eligibility for Medicaid and for the refundable credit for coverage under a qualified health plan; NELSON of Nebraska; to the Committee on Finance, July 18.

S. 1381 (TICK-BORNE DISEASES), to provide for the expansion of federal efforts concerning the prevention, education, treatment, and research activities related to Lyme and other tick-borne disease, including the establishment of a Tick-Borne Diseases Advisory Committee; BLUMENTHAL; to the Committee on Health, Education, Labor, and Pensions, July 18.

H.R. 2576 (TAXATION), to amend the Internal Revenue Code of 1986 to modify the calculation of modified adjusted gross income for purposes of determining eligibility for certain health care-related programs; BLACK; to the Committee on Ways and Means, July 18.

S. 1391 (VETERANS’ HEALTH), to amend Title 38, United States Code, to improve the disability compensation evaluation procedure of the secretary of veterans affairs for veterans with post-traumatic stress disorder or mental health conditions related to military sexual trauma, and for other purposes; TESTER; to the Committee on Veterans’ Affairs, July 20.

H.R. 2595 (NEUROLOGICAL DISEASES AND DISORDERS), to amend the Public Health Service Act to provide for the establishment of permanent national surveillance systems for multiple sclerosis, Parkinson’s disease, and other neurological diseases and disorders; VAN HOLLEN; to the Committee on Energy and Commerce, July 20.

H.R. 2600 (CHILDREN’S HEALTH), to provide for implementation of the National Pediatric Acquired Brain Injury Plan; LANCE; to the Committee on Energy and Commerce, July 20.

H. RES. 360 (HIV/AIDS), expressing support for the sixth IAS Conference on HIV Pathogenesis, Treatment, and Prevention and the sense of the House of Representatives that continued commitment by the United States to HIV/AIDS research, prevention, and treatment programs is crucial to protecting global health; HASTINGS of Florida; jointly, to the committees on Foreign Affairs and Energy and Commerce, July 20.

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