Citizens petitions prevent the new entry of drugs into the market

Kieran, 1-1-2017, “Abuse of the Hatch-Waxman Act: Mylan 's Ability to Monopolize Reflects Weaknesses”, Brooklyn Journal of Corporate , Financial, and Commercial Law, https://brooklynworks.brooklaw.edu/bjcfcl/vol11/iss2/12/#:~:text=Though%20the%20Hatch%2DWaxman%20Act,consumers%20of%20a%20generic%20option.

The citizen petition is another tactic that brand name companies use to impede competitors’ efforts to enter the market. According to the Administrative Procedure Act (APA), the FDA must provide the public with a right to petition an agency rule.78 A citizen petition is a means through which the FDA allows the public to invoke their right to petition for the issuance, amendment, or revocation of a rule, or to petition the FTC “to take or refrain from taking any other form of administrative action.”79 The citizen petition must contain, amongst other things, the factual and legal grounds for the petition.80 In theory, the right to petition a government agency allows for an “important route of dialogue” that provides the public “with an invaluable tool for getting good scientific arguments in front of the FDA.”81 In addition, the citizen petition is intended to raise valid medical and safety issues that the FDA considers, addresses, and reports on to the filing pharmaceutical company. In practice, however, brand-name companies have been able to morph this right of the people into a clever business tactic to delay FDA approval of competing generic drugs, without facing any legal or regulatory penalty for doing so. Brand-name pharmaceutical companies can ask the FDA to take a particular action against a pending ANDA through the use of a 505(q) citizen petition, the petition that brand names “are most likely to file to delay generic entry.”82 The FDA is mandated to take final action on these petitions no later than 150 days after the petition’s filing date, unless a delay would be necessary to protect the public health.83 Though the FDA must respond to the citizen petition within 150 days, it does not have to do so before it rules on the ANDA.84 Current FDA policy is to assess the citizen petition prior to approving the ANDA, but the FDA often waits to release the response to the citizen petition alongside releasing the ruling on the accompanying ANDA.85 Since the FDA often responds to the citizen petition and ANDA simultaneously, it is not difficult to imagine a situation wherein an ANDA is weeks from being approved or the brand-name drug’s patent is nearing expiration, and the brand name files a 505(q) petition at this time. This tactic effectively pushes back the approval of the ANDA by taking advantage of the FDA’s well- reasoned policy of thoroughly vetting the citizen petition before approving the ANDA. These petitions are known as “eleventh hour” petitions because companies would file them “on the eve of drug approval for the purpose of delay.”86 Brand-name manufacturers continue to file long and complex eleventh hour 505(q) petitions that push back the generic approval clock up to 150 days. Despite the 505(q) petition requirement that petitioners to certify that they did not delay in filing the petition, these eleventh hour petitions are extremely common in the pharmaceutical industry.87 “Evidence that citizen petitions are used to delay generic entry can be inferred from the vast number of petitions that the FDA denies.”88 Specifically, the FDA denied 94% of citizen petitions challenging the approval of ANDAs in 2013, 95% in 2014, and 100% in 2015.89 This tactic serves to delay the approval process of a generic drug, which the amended application process Hatch-Waxman purposely accelerated.