TITLE

CITIZEN PETITIONS: LONG, LATE-FILED, AND AT-LAST DENIED

AUTHOR(S)

CARRIER, MICHAEL A.; MINNITI, CARL

PUB. DATE

November 2016

SOURCE

American University Law Review;2016, Vol. 66 Issue 2, p305

SOURCE TYPE

Academic Journal

DOC. TYPE

Article

ABSTRACT

The pharmaceutical industry is ground zero for many of the most challenging issues at the intersection of antitrust and intellectual property law. It also presents a complex regulatory regime that is ripe for anticompetitive behavior. It thus should not be a surprise that the industry has been subject to rigorous antitrust scrutiny in recent years. While settlements between brand and generic firms and "product hopping" from one version of a drug to another have received attention, one behavior has avoided serious scrutiny. Brand firms' filing of citizen petitions with the U.S. Food and Drug Administration (FDA) has almost entirely slipped beneath the radar. While citizen petitions in theory could raise concerns that a drug is unsafe, in practice they bear a dangerous potential to extend brand monopolies by delaying approval of generics at a potential cost of millions of dollars per day. This Article offers an empirical study of "505(q)" citizen petitions, which ask the FDA to take specific action against a pending generic application. It analyzes every 505(q) petition filed with the FDA between 2011 and 2015, documenting (1) the number of petitions each year, (2) who filed the petitions, (3) the success rate of the petitions, (4) the petitions' length, (5) whether petitions were filed in close proximity to the expiration of a patent or data exclusivity, and (6) occasions in which the FDA approved generics on the same day it decided petitions. The study finds that brand firms filed 92% of 505(q) petitions. And it concludes that the FDA granted an astonishingly low 8% of petitions, rejecting a full 92%. Why is the grant rate so low? We consider several reasons. First, in the past 5 years, the average length of petitions has more than doubled, and the FDA almost never grants petitions with a length above the mean. Second, 39% of petitions are filed within 6 months of the expiration of a patent or FDA exclusivity, with almost all of these petitions denied. Third, the FDA resolved a number of petitions on the same day it approved the generic, suggesting that the Agency delayed generic approval until it resolved the petition. These three settings resulted in grants of only 3%, 2%, and 0%, respectively. The Article concludes by offering examples of serial petitions, late-filed petitions, and a combination of petitions with other behavior, such as product hopping and settlements. In short, citizen petitions represent a hidden tool in a brand firm's toolkit of entry-delaying activity that can lead to consumers paying high drug prices while providing no offsetting safety benefit.

ACCESSION #

20383102

 

Related Articles

• Speedy delivery: Bringing generics to market faster. MONKS, RICHARD // Drug Store News;10/20/2014, Vol. 36 Issue 10, p46 

  The article reports regulatory developments in the pharmaceutical sector in the U.S. as of late October 2014, particularly involving generic drugs. It cites the efforts by the Food and Drug Administration (FDA) and the Generic Pharmaceutical Association (GPhA) in finding ways to facilitate the...

• Competition from Biosimilars an Incentive for Innovation. Buffery, Dalia // American Health & Drug Benefits;Jan2010, Vol. 3 Issue 1, p27 

  The article discusses the importance of increasing access to generic medications, also referred to as biosimilars or follow-on biologics (FOBs). The use of biosimilars can help reduce medical costs and increase consumer access to affordable medications. The author argues that a new pathway for...

• Bigger Role. Bigger Target. Agres, Ted // Drug Discovery & Development;May2012, Vol. 15 Issue 5, p8 

  The article discusses the bigger role of the Food and Drug Administration (FDA) in the reauthorization of the Prescription Drug User Fee Act (PDUFA) in the U.S. It notes the five major provisions to be considered in the final bill in which FDA's new responsibilities and authorities for oversight...

• FDA agrees to deal that speeds reviews. Arnold, Matthew // McKnight's Long-Term Care News;Oct2011, Vol. 32 Issue 10, p31 

  The article reports on the agreement between the U.S. Food and Drug Administration and the biopharmaceutical industry that the Prescription Drug User Fee Act, which requires drug firms to provide about two-thirds of the amount spent by the agency on drug reviews, should be revamped.

• FDA Struggles with Risk Management and Drug Safety. Wechsler, Jill // Pharmaceutical Technology;Sep2010, Vol. 34 Issue 9, p26 

  The article reports on the move of U.S. Food and Drug Administration (FDA) to provide advantages and disadvantages of establishing Risk Evaluation and Mitigation Strategies (REMS) programs in pharmaceutical industry. The agency proposed some ways on how to prevent opioid misuse and abuse...

• Feds to pharma: Fraud cases are in our crosshairs. KALTWASSER, JARED // njbiz;11/8/2010, Vol. 23 Issue 45, p5 

  The article considers the measures taken by pharmaceutical companies in the U.S. to comply with the regulations enforced by the Food and Drug Administration (FDA). According to Jack Garvey, principal at Compliance Architects, the pharmaceutical industry has changed from being vertically...

• Generic Drug User Fee--Abbreviated New Drug Application, Prior Approval Supplement, and Drug Master File Fee Rates for Fiscal Year 2013. Kux, Leslie // Federal Register (National Archives & Records Service, Office of;10/25/2012, Vol. 77 Issue 207, p65198 

  The article reports on a notice issued by the U.S. Department of Health and Human Services' Food and Drug Administration regarding an announcement related to the rate for the Prior Approval Supplement (PAS), Abbreviated New Drug Application (ANDA) and Drug Master File (DMF) fees with respect to...

• REPORTERS Notebook.  // Drug Store News;2/9/2009, Vol. 31 Issue 2, p38 

  The article offers news briefs related to the U.S. pharmaceutical industry. Teva Pharmaceuticals introduced its levetiracetam tablets as well as its partnership with Basel to develop, manufacture and market biosimilarsin Europe. The Food and Drug Administration (FDA) approved the generic version...

• SIMPLIFYING FDASIA: THE "FAST TRACK" TO EXPEDITED DRUG APPROVAL EFFICIENCY. JAE, VERONICA S. // Administrative Law Review;Winter2014, Vol. 66 Issue 1, p173 

  No abstract available.

Read the Article