Two months ago, the Food and Drug Administration (FDA) announced a comment period on a new draft guidance intended to stop drug companies from abusing the citizen petition process to block access to new affordable generic drugs. This week, several consumer groups submitted comments supporting the draft guidance and urging the FDA to fight sham citizen petitions and promote drug access.
The comments were submitted by Mr. David Balto on behalf of Consumer Action, Consumer Reports, Families USA, Patients for Affordable Drugs NOW, Public Citizen, and the U.S. PIRG Education Fund.
Citizen petitions are a way for individuals and concerned organizations to make requests to the FDA for changes in health policy, or to point out problems with certain proposed drugs. They have a legitimate use and can be helpful. But recently, pharma companies have been manipulating the system and filing fraudulent citizen petitions not to point out genuine problems, but just to delay and obstruct approval of cheaper generic drugs. Generic drug competition is one of the most effective ways to reduce drug costs, but it is being thwarted by this manipulation.
A study by Professor Michael Carrier found that the FDA has denied 92% of all petitions and that the average length of petitions has more than doubled in the past five years; the study also lists numerous examples of serial petitions, late-filed petitions, and petitions that were filed in conjunction with other abusive behavior. As a result, the FDA released a proposed draft guidance on citizen petitions and factors it will take into account when evaluating them and deciding whether to quickly reject them. The factors include whether petitioners have taken an unreasonable amount of time to submit the petition, whether the petition has any data or information in support of its positions, whether the petition raises the same issues as an earlier petition that the FDA has already responded to, and whether the petitioners have a history of submitting petitions just to delay products.
In their comments, the consumer groups urge the FDA to interpret its statute in order "to quickly dispose of Citizen Petitions filed to game the system. As two independent studies of Citizen Petitions have shown, a greater willingness to see questionable Petitions as warranting summary disposition will have great consumer benefits with very little, if any, risk of harm." They support the FDA's stronger draft guidance and urge the FDA to continue its efforts to curb this problem. The Federal Trade Commission has also weighed in, submitting comments saying that it shares concerns about abuse of the citizen petition process.
The FDA's draft guidance to stop manipulation of citizen petitions is very welcome. We urge the FDA to continue on this path, and work to promote competition and consumer access to affordable prescription drugs.