Three Congressmen have sent a letter to Rep. John Dingell (D-MI), chairman of the House Committee on Energy and Commerce, asking for a formal hearing to probe the FDA’s handling of Dendreon’s submission for Provenge. The three Congressmen were Mike Michaud (D-ME), Tim Ryan (D-OH) and Dan Burton (R-IN).
In March, the FDA’s own advisory committee recommended the agency approve the drug, however two dissenters voted against the approval. Those two individuals then worked diligently to go back to the FDA and block approval. The FDA issued an approvable letter in May, essentially delaying the product for at least another three years.
The focus of the probe will be possible ethics violations and conflicts of interest on the part of Howard Scher and Maha Hussain. Scher is the lead investigator on a drug from Dendreon’s competitor Novacea and has been an advisor to a VC firm that invests in Novacea.
In March, the FDA’s own advisory committee recommended the agency approve the drug, however two dissenters voted against the approval. Those two individuals then worked diligently to go back to the FDA and block approval. The FDA issued an approvable letter in May, essentially delaying the product for at least another three years.
The focus of the probe will be possible ethics violations and conflicts of interest on the part of Howard Scher and Maha Hussain. Scher is the lead investigator on a drug from Dendreon’s competitor Novacea and has been an advisor to a VC firm that invests in Novacea.
Dendreon’s stock shot up 18 percent on the news.
Related coverage: