REP. WEISS QUESTIONS FDA's LATEST COLOR DEADLINE EXTENSION
REP. WEISS QUESTIONS FDA's LATEST COLOR DEADLINE EXTENSION in a letter sent to the agency Aug. 9. The letter quickly followed the agency's Aug. 2 Federal Register announcement that the provisional listing closing dates for nine color additives was extended from Aug. 3 to Oct. 2. In the letter, House Government Operations/Intergovernmental Relations and Human Resources Subcmte. Chairman Ted Weiss (D-NY) asked FDA to explain this latest in a long string of delays. Weiss reportedly asked the agency what additional information it expected to get on the safety of the colors between now and Oct. 2 that might change its current stance on the colors. Additives whose closing dates were extended include: FD&C Red No. 3, FD&C Yellow Nos. 5 and 6, D&C Red Nos. 8 and 9, D&C Red No. 33, D&C Orange No. 17 and D&C Red Nos. 19 and 37. Weiss also asked about the status of HHS Asst. Secty. Brandt's evaluation of the agency's recommendation to delist six of the dyes. In response to an earlier letter from Weiss, then FDA Acting Com. Novitch justified the last color deadline postponement -- from June 4 to Aug. 3 -- by pointing out that the additional time gave Brandt "an opportunity to evaluate fully the agency's recommendations." Novitch sent a "decision memo" to HHS in late March which advised that FD&C Red No. 3, D&C Red Nos. 8/9, D&C Orange No. 17 and D&C Red Nos. 19/37, be banned. Weiss' subcmte. launched its review of the FDA color additives program in March.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth