FDAnews
www.fdanews.com/articles/101311-pharma-and-device-blog-watch

Pharma and Device Blog Watch

November 20, 2007

DTC User Fees: Will This Program Fly? (The IN VIVO Blog)
The FDA’s new program to allow prescription drug companies to pay for a pre-review of direct-to-consumer (DTC) television ads is struggling to get off the ground, Michael McCaughan writes.

The FDA has received commitments from industry to submit 47 ads with roughly a week before the first critical deadline to create DTC user fees. “That is about 20 short of the absolute minimum necessary to get the new review system up and running — and way short of the 150 ads used as the benchmark in creating the plan,” McCaughan says.

The program and user fees were created by the FDA Amendments Act, which was signed into law Sept. 27. The user fee is voluntary, which means sponsors must first give the FDA a commitment to participate before the agency can calculate the fees and send out invoices, according to the blog.

“But if everyone waits, the entire program will shut down. The law stipulates that FDA must collect at least $11.25 million to get the program up and running by Jan. 25. Since there is a cap set on the fee, that means FDA must get commitments from industry for 68 ads in order for the program to take off,” McCaughan writes.

Don’t Like What a Thought Leader Has to Say — Try Intimidation (World of DTC Marketing)
A recent report that GlaxoSmithKline (GSK) intimidated a thought leader who spoke out against Avandia has come at a bad time for the drug industry, and to make it right, GSK should immediately terminate those responsible, Richard Meyer writes.

“It is well known that pharma will do anything to [not] lose sales from a blockbuster. … But what we have here is a pharma company so willing to defend the sales of one of its drugs that it went way out of bounds and more importantly was not thinking of the patients’ health but of [its] own pocketbooks and stock price,” he says.

The founders of these companies believed that profits would come as a result of producing and marketing a good product. Pharma CEOs are more interested in protecting stock prices than ensuring that products meet patient needs, according to the blog. The lack of transparency makes patients more confused by the conflicts in data, and pharma has done nothing to resolve these issues.

“Take the latest Actos ads that tout it as a replacement for Avandia. A full page ad [appeared] in the Times today but the fair balance was only three-quarters of a page in small print that would have taken a college PhD to decipher,” Meyer writes.