Health Care in The United States - Drug Efficacy and Safety

Drug Efficacy and Safety

See also: Regulation of therapeutic goods in the United States

The Food and Drug Administration (FDA) is the primary institution tasked with the safety and effectiveness of human and veterinary drugs. It also is responsible for making sure drug information is accurately and informatively presented to the public. The FDA reviews and approves products and establishes drug labeling, drug standards, and medical device manufacturing standards. It sets performance standards for radiation and ultrasonic equipment.

One of the more contentious issues related to drug safety is immunity from prosecution. In 2004, the FDA reversed a federal policy, arguing that FDA premarket approval overrides most claims for damages under state law for medical devices. In 2008 this was confirmed by the Supreme Court in Riegel v. Medtronic.

On 30 June 2006, an FDA ruling went into effect extending protection from lawsuits to pharmaceutical manufacturers, even if it was found that they submitted fraudulent clinical trial data to the FDA in their quest for approval. This left consumers who experience serious health consequences from drug use with little recourse. In 2007, opposition was raised in the Congressional House to the FDA ruling, but the Senate upheld the status quo. On 4 March 2009, an important U.S. Supreme Court decision was handed down. In Wyeth v. Levine, the court asserted that state-level rights of action could not be pre-empted by federal immunity and could provide "appropriate relief for injured consumers." In June 2009, under the Public Readiness and Emergency Preparedness Act, Secretary of Health and Human Services Kathleen Sebelius signed an order extending protection to vaccine makers and federal officials from prosecution during a declared health emergency related to the administration of the swine flu vaccine.