Bills, Bills, Bills – An Update on Legislative Proposals

It has been a while since providing an update on legislative proposals introduced in Congress that would impact the FDA, medical products and food industries.  With Congress out on recess, it seemed like a good time to catch up on our bills.  Here are some that have been introduced since last listed here on the blog in February.

FDA Related Bills Affecting Medical Products

  • H.R.1483 – Drug Safety Enhancement Act of 2011 – Requires drug manufacturers to: (1) implement an effective quality system that requires compliance with current good manufacturing practices and timely communication of product quality issues; (2) establish risk management procedures that ensure effective risk assessment, control, and communication; and (3) establish procedures that ensure the safety, identity, quality, strength, purity, and security of all drugs and other materials used by the manufacturer;
  • H.R. 1862 - Regenerative Medicine Promotion Act of 2011Authorizes the Secretary, acting through FDA Commissioner, to: (1) conduct, support, or collaborate in regulatory research to assist FDA in performing its functions with respect to regenerative medicine; or (2) make grants to fund regulatory research for such purpose;
  • S.319Pharmaceutical Market Access and Drug Safety Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States

FDA Related Bills Affecting Food and Dietary Supplements

  • H.R. 1486 – Trans Fat Truth in Labeling Act of 2011 – Directs FDA to promulgate a final regulation revising federal nutrition labeling regulations to: (1) require the label of a food that has less than 0.5 grams and greater than 0.0 grams of trans fat per serving to contain an asterisk or other notation and a note that the food has a low trans fat content per serving, and (2) prohibit the label or labeling on such a food from indicating that the trans fat content per serving is zero.
  • H.R. 2044 - Health Freedom Act – Prohibits the federal government from preventing the use of a claim describing any nutrient in a food or dietary supplement as mitigating, treating, or preventing any disease, disease symptom, or health-related condition unless, in a final order following a trial on the merits, a federal court finds clear and convincing evidence, based on qualified expert opinion and published peer-reviewed scientific research, that: (1) the claim is false and misleading in a material respect; and (2) there is no less speech-restrictive alternative to claim suppression that can render the claim non-misleading. Defines the term “material” to mean that FDA has identified a competent consumer survey demonstrating that consumers decided to purchase the food or dietary supplement based on the portion of the claim alleged to be false or misleading.
  • S.50Commercial Seafood Consumer Protection Act - Among other things directed at other agencies, directs the Secretary to increase the number of laboratories certified to FDA standards in the United States and in countries that export seafood to the United States to analyze food and ensure that the laboratories comply with applicable federal laws.
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