WASHINGTON AstraZeneca Plc is urging U.S. lawmakers to revive a program for drugmakers who want to voluntarily submit their television commercials for regulatory review, according to a letter provided to Reuters.
Congress created the program last year but it has not taken effect. Lawmakers failed to give the U.S. Food and Drug Administration full authority to collect and spend industry fees that would fund the reviews.
AstraZeneca wrote to four senior lawmakers on Thursday asking them to encourage their colleagues to provide the necessary FDA power for the effort to begin.
"Without such resources, (FDA's advertising division) cannot timely review ads and some biopharmaceutical companies, regrettably, may forgo advisory reviews," AstraZeneca wrote.
Some lawmakers oppose having the industry fund more FDA activities. Drug and medical device makers pay hundreds of millions of dollars each year for product reviews and other work. Critics say the funding may pressure FDA staff to act in the interest of companies instead of the public.
Pharmaceutical companies pushed for the ad-review program to address criticism that their widespread promotions led to unnecessary prescribing and at times ventured into hype.
Some companies submit their commercials to the FDA for review now, but staff to evaluate the ads is limited.
If Congress does not fully authorize the industry fees, AstraZeneca urged the lawmakers to add more taxpayer funding for FDA ad reviews.