So far, the House is using its best opportunity in 5 years to overhaul our drug safety system wisely…let’s hope it stays that way. House committee members voted to match the Senate with an additional $225 million in industry fees for drug safety over the next 5 years. The House bill also matches the Senate in giving the FDA the authority to require follow-up safety studies and label changes.
House bill has tougher fines and tougher conflict of interest rules for advisory committees. And, no surprise here…pressure from industry/advertising pushed members to take away moraturium on drug ads that was in draft. Instead, drug companies will be fined for “false or misleading” ads, a maximum penalty of $250,000 for the first offense and $500,000 for subsequent offenses. These fines are tougher than what the Senate passed and will hopefully dissuade PhRMA from running false ads. Sorry, I can’t exactly read through their “Guiding Principals on direct-to-consumer ads” with a straight face. And amendment pushed by victim-advocate Kim Witczak, that would require an 800 number on all drug ads to report adverse events to the FDA was included!
Overall, good news. One area of some concern: we hope that requirement of clinical trial reporting will not be weakened, as the Senate’s was. The public should have ALL results of clinical studies, not just those cherry picked by industry.
So, this bill will go to House floor after July 4th recess, and then to conference committee. It’s there that differences between the two bills will have to be worked out. We’ll need to keep the pressure on to keep these stronger House reforms intact.