Sen. Brown Introduces COOL Bill Requiring Country-Of-Origin Labeling for Drugs
October 2, 2008Earlier this week, Senator Sherrod Brown (D-OH) announced the introduction of S. 3633, the “Transparency in Drug Labeling Act.” The bill, also know as the “COOL Pharmaceutical Bill,” would amend the FDC Act to require Country-Of-Origin (“COO”) labeling on prescription and Over-The-Counter (“OTC”) drug products.
Specifically, the bill would amend FDC Act § 502 so that a prescription drug would be misbranded unless the labeling of such drug bears the following two separate lists:
(1) The identity of the country of manufacture of each active ingredient of the drug, listed in descending order based on the percentage of the number of active ingredients in the final dosage form manufactured in such countries; and
(2) The identity of the country of manufacture of each inactive ingredient of the drug, listed in descending order based on the percentage of the number of inactive ingredients in the final dosage form manufactured in such countries.
Similarly, an OTC drug would be misbranded unless the label of such drug bears the following two separate lists:
(1) The identity of the country of manufacture of each active ingredient of the drug, listed in descending order based on the percentage of the number of active ingredients in such drug manufactured in such countries; and
(2) The identity of the country of manufacture of each inactive ingredient of the drug, listed in descending order based on the percentage of the number of inactive ingredients in such drug manufactured in such countries.
Sen. Brown has been a champion of COO labeling. Earlier this year, Sen. Brown reportedly led a successful effort to include mandatory COO labeling for meat and produce in the 2008 Farm Bill. Also earlier this year, Sen. Brown sent letters to Pfizer and Merck (see July 24, 2008 Pharmalot post) requesting information on the extent to which Pfizer purchases active pharmaceutical ingredients from foreign countries, and how Merck guarantees the safety of pharmaceutical ingredients and its finished drugs. Sen. Brown has also requested that FDA evaluate drug company outsourcing and its effects on drug safety.
S. 3633 has been referred to the Senate Health, Education, Labor, and Pensions Committee. It seems unlikely, given ongoing debate over the economic stabilization package and the upcoming election, that S. 3633 will be passed in the 110th Congress.