FDA to screen TV drug ads; tentative user-fee pact set: WSJ

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The FDA would screen television ads from drug companies under a new pact between agency and industry, The Wall Street Journal reported Monday. Fees from the pact would help FDA hire new staff to review the industry’s TV ads, wrote the Journal. The agreement on TV ad fees was proposed along with a separate, five-year PDUFA accord setting higher user fees, with more going to fund drug-safety initiatives, the Journal said. To take effect, HHS must sign off on both pacts, and they must be approved by Congress. They would begin in the government’s fiscal 2008, which starts Oct. 1, 2007. The Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) declined comment to MM&M. Both said they were bound by confidentiality restrictions until a new PDUFA agreement is published in the Federal Register. During fiscal year 2007, the last year of the current user-fee agreement, the FDA is expected to get more than $300 million in fees. The proposed agreement would up that figure by about one-third in fiscal 2008, the Journal said. About $30 million of the increase would fund post-marketing safety activities. The FDA agreed to give drug makers a projected time line to review new-drug applications about 2 1/2 months after receiving the applications. The agency would aim to adhere to its deadlines and report on its results. The statutory review time for priority drugs is six months. For medications designated as standard, the goal is 10-12 months. As for the TV ad vetting pact, companies would pay about $40,000 to $50,000 at the beginning of each year for each TV ad campaign they planned to air that year. The amount could be higher if few companies sign up and the FDA faces a budget shortfall; its annual target is $6 million in fees. Fees would be double in the first year to create a reserve fund. In return, the agency would try to review TV ads within 45 days. Additional money under the new user-fee deal also would be used to add drug-review staff, develop new drug-development guidelines, improve IT systems and help pay for the FDA’s move to a new office building. DDMAC recently added a second DTC review group to cope with a crush of new ads. The agency reviewed 9,285 consumer promotions in 2005 – up from 8,417 in 2004 – and the number of consumer promotions is thought to have skyrocketed since the implementation of PhRMA’s DTC guidelines late last year.
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