Energy and Commerce Committee Passes Drug Bill With Towns-Buyer Amendment Language
At yesterday's markup of the drug safety bill, the House Energy and Commerce Committee preserved language passed during the Health Subcommittee markup that replaced five provisions in the original that would have imposed burdensome restrictions on advertising:
A three-year ban on ads for new medications;
- Preapproval of ad content by the FDA;
- Mandated warning language about nonspecific, unidentified possible adverse events;
- A mandated "black triangle" warning symbol for all new drugs; and
- Preapproval of a medication's marketing plan by FDA.
Instead, the bill contains language sponsored by Reps. Ed Towns (D-NY) and Steve Buyer (R-IN) that sets civil monetary penalties for false or misleading drug advertising. While the penalties were increased in this provision at the markup, we were able to defeat provisions that would have gone substantially higher and further.
The bill now moves on to the House floor, which is expected to take it up sometime after the Independence Day recess. As the package of health bills is considered "must pass" legislation due to the expiration of FDA user fees, we will continue to monitor the situation as the bill progresses through the House and to a likely conference with the Senate.
Additionally, as a class example of "whack-a-mole," we learned that Rep. Pete Stark (D-CA) has just reintroduced legislation to require a "fair balance" of risk and benefit information in drug ads. If an ad failed to provide "fair balance," the manufacturer would be unable to claim the ad as a business expenses for tax purposes. The bill would also disallow the tax deduction for advertising of new drugs for two years. This is similar to legislation Rep. Stark has introduced in multiple Congresses. It would very clearly be unconstitutional, but Rep. Stark is the Chairman of the Health Subcommittee of the Ways and Means Committee, so it bears watching.
We will have a more in-depth analysis of the Towns-Buyer provisions in the near future. If you have any questions about this or any other issue, please contact Dan Jaffe in ANA's Washington office at 202-296-2359 or at email@example.com.