Drug marketers continue to skimp on product risks in their ads, and would do well to flip the ad, reversing the benefit-to-risk balance in order to get the FDAs point on fair balance.
Resource-strapped though it is, the FDAs DDMAC is expanding its surveillance to cover the industrys growing use of Internet blogs and product placements in popular TV shows.
Reps claim FDA met with industry more than other groups
The FDA met with industry 24 times as often as it did with patient and consumer groups in preparing its current user fee renewal proposal for Congress, Reps. Maurice Hinchey (D-NY) (and Bart Stupak (D-MI) said.
Public Citizen has filed a citizen petition with the FDA asking that agency experts be required to give a scientific presentation at all advisory committee meetings that review specific drug products.
KV Pharmaceutical e-mail alert overstated drug efficacy
The FDA says a KV Pharmaceutical e-mail alert announcing the availability of Clindesse on a formulary overstated and misrepresented the efficacy of the drug, which is indicated for treating bacterial vaginosis.
Pennsylvania’s PACE (Pharmaceutical Assistance Contract for the Elderly) program, which spends $600 million each year on drugs for 300,000 poor senior citizens, is spending $3 million over three years on a pilot counter-detailing program to balance the efforts of drug company reps, according to the Philadelphia Inquirer.
The FDA’s Medication Guide (MedGuide) program was the object of intense criticism from reps of retail pharmacy organizations, consumer groups and academic researchers at a public hearing by the agency in June.
Sens. Edward Kennedy (D-MA), Orrin Hatch (R-UT), Hillary Clinton (D-NY) and Mike Enzi (R-WY) have agreed on legislation to approve follow-on biologics.
American Enterprise Institute resident fellow and former FDA deputy Scott Gottlieb told a Drug Information Association conference in June that there is “fairly strong” sentiment within the agency favoring creation of a third, behind-the-counter (BTC) drug class between Rx and OTC.