Source: https://columbialawreview.org/content/five-actions-to-stop-citizen-petition-abuse-2/
Timestamp: 2018-06-22 05:08:32
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Matched Legal Cases: ['§ 10', '§ 10', '§ 553', '§ 914', '§ 355', '§ 10', '§ 355', '§ 355', '§ 355', '§ 355', '§ 355', '§ 355', '§ 355', '§ 355', '§ 355']

FIVE ACTIONS TO STOP CITIZEN PETITION ABUSE - Columbia Law Review
Columbia Law Review FIVE ACTIONS TO STOP CITIZEN PETITION ABUSE
* Distinguished Professor of Law, Rutgers Law School. I would like to thank Kurt Karst and Carl J. Minniti III for their helpful comments.
High drug prices are in the news. In some cases, such as AIDS-treating Daraprim
1 Zoë Schlanger, Martin Shkreli on Raising Price of AIDS Drug 5,000 Percent: ‘I Think Profits Are a Great Thing,’ Newsweek (Sept. 21, 2015), http://www.newsweek.com/
martin-shkreli-daraprim-drug-prices-374922 [http://perma.cc/L4LA-RWL4].
and the life-saving EpiPen,
2 Emily Willingham, Why Did Mylan Hike EpiPen Prices 400%? Because They Could, Forbes (Aug. 21, 2016), http://www.forbes.com/sites/emilywillingham/2016/08/
21/why-did-mylan-hike-epipen-prices-400-because-they-could/#6d42bdb6280c [http://
perma.cc/PGQ2-AV49].
the price increases dramati­cally. In other cases, which have received less attention, the price stays high longer than it should. Either way, anticompetitive behavior often lurks behind inflated prices.
By delaying price-reducing generic competition, this behavior forces consumers to spend billions of extra dollars each year. Brand drug companies have engaged in an array of conduct to delay generic entry. They have entered into agreements by which they pay generic manufacturers to settle patent litigation and delay entering the market.
3 E.g., FTC v. Actavis, 133 S. Ct. 2223, 2229 (2013) (holding that settlements involv­ing payment and delayed entry could have “significant adverse effects on competition” and violate antitrust law).
They have engaged in “product hopping,” switching from one version of a drug to another, often to delay generic entry.
4 E.g., New York ex rel. Schneiderman v. Actavis PLC, 787 F.3d 638, 643 (2d Cir. 2015) (describing “product hopping” as “conduct by a monopolist to perpetuate patent exclusivity through successive products”).
And they have restricted their distribution systems to prevent generics from obtaining needed sam­ples.
5 See Michael A. Carrier et al., Using Antitrust Law to Challenge Turing’s Daraprim Price Increase, 31 Berkeley Tech. L. J. 1379, 1386 (2016).
Another one of these strategies, which has flown under the radar until recently, involves “citizen petitions” filed with the U.S. Food and Drug Administration (FDA). Although intended to serve the public interest by bringing safety concerns to the agency’s attention, nearly all petitions today that target generic drugs are denied.
6 See Michael A. Carrier & Carl J. Minniti III, Citizen Petitions: Long, Late-Filed, and At-Last Denied, 66 Am. U. L. Rev. 305, 308 (2016) [hereinafter Carrier & Minniti, Citizen Petitions] (finding that the FDA denies 92% of petitions targeting pending generics).
Despite the low suc­cess rate, petitions are still able to delay generic entry and hamstring the FDA. This Piece provides an overview of citizen petitions and the anti­competitive harm they threaten and offers five solutions to address the problem posed by abusive citizen petitions.
Citizen petitions allow any party to raise safety or effectiveness con­cerns with drugs the FDA is considering for approval.
7 See, e.g., 21 C.F.R. § 10.25(a) (2016) (“An interested person may petition the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action.”); id. at § 10.30 (specifying requirements of citizen petitions).
The petitions, with a foundation in the First Amendment
8 U.S. Const. amend. I (“Congress shall make no law . . . abridging the freedom . . . to petition the Government for a redress of grievances.”).
and Administrative Procedure Act,
9 5 U.S.C. § 553(e) (2012) (requiring government agencies to provide the public with “the right to petition for issuance, amendment, or repeal of a rule”).
in theory play an important role in ensuring that drugs are safe and effective. In practice, however, brand firms have used peti­tions to delay generic approval, extending monopolies on their products at a potential cost to consumers of millions of dollars per day. In many cases, petitions offer little incremental value to the review process but require considera­ble time, with the FDA forced to address the merits of every petition, many of which contain “detailed analysis and precise scien­tific doc­umentation” and require review by “multiple disciplines” within the agency.
10 The Generic Drug Maze: Speeding Access to Affordable, Life-Saving Drugs: Hearing Before the S. Spec. Comm. on Aging, 109th Cong. 14 (2006) (statement of Gary Buehler, Director, Office of Generic Drugs, FDA).
One type of petition has caused particular concern. As part of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Congress created Section 505(q),
11 Pub. L. No. 110-85, § 914, 121 Stat. 823, 953–57 (2007) (codified at 21 U.S.C. § 355(q) (2012)).
which applies to “certain petitions that request that the FDA take any form of action” related to a pending Abbreviated New Drug Application (ANDA or “generic application”).
12 153 Cong. Rec. 25,047 (2007).
Congress intended to reduce delays
13 Ctr. for Drug Evaluation and Research, U.S. Dep’t of Health and Human Servs., OMB Control No. 0910-0679, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry 1 (2014) [hereinafter Guidance for Industry], http://www.fda.gov/downloads/drugs/
guidancecomplianceregulatoryinformation/guidances/ucm079353.pdf [http://perma.cc/
F9V2-X46A].
by requiring petitioners to certify that they did not delay in filing the petition
14 See 153 Cong. Rec. 25,047.
and mandating that the FDA take final action no later than 180 days
15 21 C.F.R. § 10.30(e)(2) (2016).
(later shortened to 150 days) after the petition’s filing date, unless delay would be necessary to protect the public health.
16 Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112-144, 126 Stat. 993 (2012). For a discussion of how the legislation has not been successful, see infra notes 37–38 and accompanying text.
Brand firms have filed the vast majority of 505(q) petitions, seeking additional testing or questioning whether generics are bioequivalent— that is, able to be absorbed into the body at the same rate.
17 See Carrier & Minniti, Citizen Petitions, supra note 6, at 328.
The FDA denied 92% of 505(q) petitions filed between 2011 and 2015, with this figure rising to 98% for petitions filed within six months of the expiration of a patent or FDA exclusivity date.
18 Id. at 333, 341. “FDA exclusivity” refers to a period in which the agency cannot approve other products because of, for example, the development of a drug with a new active ingredient, see 21 U.S.C. § 355(j)(5)(F)(ii) (2012), or the running of new clinical trials, see id. § 355(c)(3)(E)(iii).
In addition to these general find­ings, particular examples demonstrate anticompetitive harm in the form of:
Multiple petitions (such as Teva’s eight petitions on MS-treating Copaxone and Shire ViroPharma’s twenty-four peti­tions on the medication treating a life-threatening gastroin­testinal infection);
19 See Carrier & Minniti, Citizen Petitions, supra note 6, at 344–46; see also Complaint for Injunctive and Other Equitable Relief at 14, FTC v. Shire ViroPharma Inc., No. 1:17-cv-00131-UNA (D. Del. filed Feb. 7, 2017), 2017 WL 525426 (noting that twenty-four petitions were submitted to the FDA).
Late-filed petitions (such as Bayer Healthcare filing a peti­tion one day before the expiration of the patent on Mirena, a long-acting intrauterine device (IUD));
20 Carrier & Minniti, Citizen Petitions, supra note 6, at 346–47.
The combination of citizen petitions and product hopping (as shown by acne-treating Doryx);
21 Id. at 347–49.
The combination of petitions and entry-delaying settlements (as shown by Mylan’s allergic emergency–treating EpiPen).
22 Id. at 350–51; Michael A. Carrier & Carl J. Minniti III, The Untold EpiPen Story: How Mylan Hiked Prices by Blocking Rivals, 102 Cornell L. Rev. Online 53, 64–66 (2017) [hereinafter Carrier & Minniti, How Mylan Hiked Prices].
To pick one example, in February 2017, the FTC filed its first com­plaint challenging citizen petition conduct as an antitrust violation.
23 Complaint for Injunctive and Other Equitable Relief, supra note 19, at 14.
The FTC alleged that ViroPharma “inundated the FDA” with twenty-four citizen petitions and twenty-two other filings, which was “by far the most filings that any firm has ever made to the FDA concerning a single drug product.”
24 Id. at 1–2.
The agency alleged that “[t]hese repetitive, serial, and merit­less filings lacked any supporting clinical data” but that “ViroPharma’s campaign had succeeded in delaying generic entry at a cost of hundreds of millions of dollars.”
Not only do petitions threaten the public but they also harm the FDA, which has lamented the deluge of petitions that has forced it to expend resources “at the expense of completing the other work of the Agency.”
26 FDA, Report to Congress: Eighth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2015, at 1–8 (2016) [hereinafter FY 2015 Report], http://www.fda.gov/downloads/
AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM517279.pdf [http://perma.cc/5UN7-T9NL].
The FDA also bemoaned the “strain on Agency resources” from Congress’s reduction of the response period by 30 days to 150 days, which “affords [the] FDA even less time to evaluate the issues raised in the petitions and to provide a response that articulates the scientific and legal reasoning supporting the Agency’s decision.”
27 FDA, Report to Congress: Seventh Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2014, at 10 (2015) [hereinafter FY 2014 Report], http://www.fda.gov/downloads/
AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM464282.pdf [http://perma.cc/XZG8-N5BB].
In addition, the FDA has revealed frustration with “serial 505(q) petitions, frequently from the same petitioner, about the same specific drug or class of drugs” that require “several separate responses about different issues regarding the same product.”
The FDA’s concerns are accompanied by the public’s difficulty in uncovering information about petitions, which obscures the prevalence of the conduct and the full extent of the delay. The government website regulations.gov is difficult to navigate,
29 For example, www.regulations.gov requires a researcher looking for 505(q) petitions to comb through individual petitions filed with the FDA and identify those petitions that include a 505(q) certification statement.
leading to dependence on the privately compiled collection at FDALawBlog.
30 FDA Citizen Petition Tracker, FDA Law Blog, http://www.fdalawblog.net/
fda_law_blog_hyman_phelps/files/CPTracker.xls (on file with the Columbia Law Review) (last visited Aug. 15, 2017).
Moreover, the FDA does not provide a comprehensive account of delay from petitions targeting generics. In its annual reports to Congress, the FDA has found “delayed approvals” on only ten occasions between 2008 and 2015.
31 FY 2015 Report, supra note 26, at 8.
The agency, however, does not specify these petitions, nor does it consider a petition delayed if it responds within the 150-day period.
32 FY 2014 Report, supra note 27, at 9 (finding that “a petition answered within the [150-day] statutory deadline does not delay approval of a pending application”).
Relatedly, the FDA has failed to consider that it could be delaying generic approval by not approving the generic until it resolves the petition.
33 See infra Part III.
Congress attempted to address concerns presented by citizen peti­tions in the FDAAA.
34 See supra notes 11–16 and accompanying text.
It allowed the FDA to delay its approval of a ge­neric only if the delay was “necessary to protect the public health.”
35 21 U.S.C. § 355(q)(1)(A)(i) (2012).
And it required that the agency provide certain types of information to Congress each year.
36 See infra note 39 and accompanying text (listing requirements of annual reports submitted to Congress).
But this legislation was not successful in its goal of “stop[ping] frivolous petitions from delaying generic entry,”
37 153 Cong. Rec. 10,924 (2007) (statement of Sen. Debbie Stabenow).
as the num­ber of petitions increased after the law went into effect and has shown no signs of abating.
38 See Michael A. Carrier & Daryl Wander, Citizen Petitions: An Empirical Study, 34 Cardozo L. Rev. 249, 282 (2012).
This Piece picks up where the FDAAA left off, proposing five solutions to the citizen petition problem: (1) increasing transparency; (2) shedding light on simultaneous decisions on peti­tions and generic approval; (3) facilitating the FDA’s summary disposi­tions of petitions; (4) addressing resource waste; and (5) promoting timely filed petitions.
II. Enhance Transparency
The first proposal would increase transparency. The FDA currently is required to provide annual reports to Congress that specify certain types of information:
“[T]he number of applications that were approved during the preceding 12-month period”;
“[T]he number of such applications whose effective dates were delayed by [the above-referenced] petitions”;
“[T]he number of days by which such applications were so delayed”; and
“[T]he number of such petitions that were submitted during such period.”
39 21 U.S.C. § 355(q)(3).
Despite this information, the FDA never explains which petitions it believes have resulted in delay. And again, the agency considers a petition to be delayed only if it does not respond within the 150-day period.
It is possible, however, that a petition leads to delayed entry even within the 150-day period. The FDA, for example, might approve a generic later than it would have if the petition had not been filed. For these reasons, Congress should require the FDA to specify additional categories of information, including:
Every 505(q) petition;
The timing of the petition in relation to the expiration date of patents listed in the Orange Book
41 The Orange Book is an annual compilation of drugs and their associated patents. FDA, Approved Drug Products with Therapeutic Equivalence Evaluations (37th ed. 2017), http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/pdf [http://perma.cc/A663-TYBX].
for the brand drug referenced by the generic application;
The time the FDA expended on the petition; and
The delay (if any) in generic approval caused by the petition and determination of how the delay is calculated.
The FDA can provide this information in its annual report to Congress or on its website (like it does for patents listed in the Orange Book, generic applications, and products requiring Risk Evaluation and Mitigation Strategies (REMS)
42 REMS, which often take the form of restrictions on a drug’s distribution, ensure that a drug’s benefits outweigh its risks. 21 U.S.C. § 355-1(a)(1).
). Each of the categories would address certain current deficiencies. By providing a list of every 505(q) petition, the FDA would make it significantly easier to research and analyze peti­tions. Including information on when the petitions were filed would high­light late filings in relation to patents. The third category would, as discussed in more detail below,
43 See infra Part V (discussing the FDA’s time and cost expenditure on each petition).
shed light on FDA resources expended on petitions. And the fourth category would provide more useful infor­mation than is currently available on delay from petitions.
In short, these additional categories would provide valuable infor­mation that is currently missing and would highlight the significant con­cerns presented by citizen petitions.
III. Elucidate Simultaneous Resolutions
A second proposal targets a particular instance of transparency, which involves simultaneous determinations. On certain occasions, the FDA denies a citizen petition at the same time it grants generic approval. Some of these decisions occur within a short time (for example, one month) of each other while others occur on the same day. Although the FDA has never acknowledged doing so, industry observers have com­mented that the agency’s “practice for many years has been to simultane­ously announce both decisions.”
44 Kurt R. Karst et al., How FDA Announces Drug Approval Decisions: A Broken FDA “System” that Must Be Fixed, FDA Law Blog 1, http://www.fdalawblog.net/wp-content/uploads/archives/docs/Drug%20Approval%20Decision%20Paper.pdf [http://
perma.cc/QF4E-UCM7] (last visited Jan. 31, 2018).
The FDA’s control over the timing of decisions relating to petitions and generic approval has been criticized, with one court lamenting the “mess” that prevented “the opportunity to actually review the FDA’s actual decision and actual reasoning” on the citizen petition before the agency reached a decision on the generic application.
45 Id. at 5 (citing AstraZeneca Pharms. LP v. Burwell, 197 F. Supp. 3d 53 (D.D.C. 2016)); cf. id. at 3–4 (citing Hi-Tech Pharmacal Co. v. FDA, 587 F. Supp. 2d 1 (D.D.C. 2008)) (expressing “concern that FDA would be making a decision on exclusivity without either company having the ability to challenge that decision before facing irreparable harm”).
An industry ex­pert concluded that “the current FDA system to announce . . . hotly con­tested decisions is broken,” with “whatever advantage” the agency “may think it is getting from hiding the ball from the world on the timing and substance of these decisions . . . more than overcome by the criticism the Agency has received from judges.”
When the FDA issues simultaneous rulings, one concern is that the generic would have been approved earlier absent the petition. As dis­cussed above, petitions often require multiple divisions of the FDA to review detailed documentation, slowing down the approval process.
47 See supra note 10 and accompanying text.
But as long as the decision is reached within 150 days, the FDA does not count these as instances of delay in its annual report.
48 See supra note 32 and accompanying text.
For example, the FDA asserts that there is no delay when the 150-day period ends before the generic is “ready for approval,” without considering whether the peti­tion itself delayed approval.
49 FY 2014 Report, supra note 27, at 9.
This position seems inconsistent with the agency’s guidance. In determining whether a petition would delay a generic application (which is allowed only to protect health),
50 21 U.S.C. § 355(q)(1)(A) (2012).
it applies a “but for” test to deter­mine delay that asks if the generic would be “ready for approval but for the issues raised by the petition.”
51 Guidance for Industry, supra note 13, at 8.
Given the information currently available to the public, it is not possible for observers to determine this. Applying its “but for” analysis, the agency should make clear when it was likely to have approved the generic absent the petition.
A second concern is that the FDA delays announcing a petition deci­sion it has already reached until it formally approves the generic applica­tion. In this scenario, the petition does not delay the generic, but the FDA delays the announcement of the petition’s denial so that it is made simultaneously with the generic’s approval. The FDA may engage in this conduct to eliminate the possibility of judicial review of the petition decision.
The FDA has demonstrated concern that rulings on petitions “consti­tute final Agency action and are subject to immediate review by the courts.”
52 Id. at 14; see also Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets, 81 Fed. Reg. 78,500, 78,504 (Nov. 8, 2016) (“FDA is considered to have taken final Agency action on a petition if either: (1) FDA makes a final decision . . . during the 150-day period or (2) the 150-day period expires without FDA making a final decision.”).
As a result, petition rulings “carry with them none of the procedural rights . . . that attach to a decision to deny” generic approval.
53 Guidance for Industry, supra note 13, at 14 (explaining how, after the FDA denies an application for approval, it “must give the applicant notice of an opportunity for a hearing on whether the application is approvable, with a specific timeframe and process”).
Rulings on petitions before decisions on generic approval thus “could interfere with the statutory and regulatory scheme governing the review of applications and related procedural rights of applicants.”
More skeptically, the FDA may be delaying petition rulings so that it is less likely to be sued in court. A petition denied before generic approval may be appealed to the courts, but one announced simultane­ously with the approval decision is less likely to be challenged since in that case the generic has received approval and may be on the market shortly thereafter, which would dissuade a brand firm seeking to keep a generic off the market.
Shedding light on the timing of simultaneous decisions—including determinations of (1) when the generic would have received approval absent the petition and (2) when the FDA would have announced the petition decision absent the pending generic application—would help resolve these contentious issues.
IV. Facilitate Summary Disposition
Third, Congress could make it easier for the FDA to quickly dispose of certain petitions. Because the legislature understood that some peti­tions raised significant concern, it allowed the FDA to summarily dispense with them. This authority, however, has never been used.
55 See Sarah Zhang, How Pharma Companies Use ‘Citizen Petitions’ to Keep Drug Prices High, Atlantic (Mar. 8, 2017), http://www.theatlantic.com/health/archive/2017/
03/pharma-citizen-petitions-drug-prices/518544/ [http://perma.cc/735VG7QM] (“[T]he FDA can summarily deny petitions that it finds frivolous—but it never has.”).
The reason is that the standard is too high. Section 505(q)(1)(E) requires the FDA to conclude that a petition is “submitted with the pri­mary purpose of delaying” the generic application and that “the petition does not on its face raise valid scientific or regulatory issues.”
56 21 U.S.C. § 355(q)(1)(E) (2012).
But the provi­sion “has neither curbed the filing of petitions submitted with the primary purpose of delay” nor “permitted FDA to dispose of such peti­tions without expending substantial amounts of resources.”
57 FY 2014 Report, supra note 27, at 10.
As the agency has explained, the standards for summary disposition are “extremely difficult to meet.”
For starters, the FDA cannot deter­mine a petitioner’s primary purpose based on the petition itself. Merely reviewing such a document, which includes safety or effectiveness con­cerns, cannot reveal the filer’s purpose, let alone its primary purpose.
Moreover, even a petition that ultimately is denied will tend not to reveal “on its face” that it “does not . . . raise valid scientific or regulatory issues.”
59 21 U.S.C. § 355(q)(1)(E).
Petitions will include language and sometimes documentation challenging a drug’s safety or efficacy that at first glance may sound plausi­ble. The FDA would be hesitant to rule in a cursory review that the petition does not raise valid issues. Its concern is obvious: that errone­ously granted summary dispositions result in safety mishaps years down the road.
What can be done? First, remove the two conditions. The FDA can­not determine purpose from the petition itself, nor can it dismiss peti­tions raising safety or effectiveness concerns based on a document’s “face.”
In place of these requirements, the agency could focus on timing. Legitimate petitions should be filed within a reasonably short time of dis­covering the safety or efficacy concern. Late-filed petitions raise the con­cern that the petitioner is gaming the system, often by waiting until a generic is about to enter the market to file even though it was long aware of the information forming the basis of the petition.
As one example, Mylan received widespread notoriety for its price in­creases on the life-saving epinephrine-autoinjector EpiPen device.
60 See Willingham, supra note 2.
Not receiving as much attention was Mylan’s filing of a petition challeng­ing Teva’s EpiPen alternative at least five years after it most likely was aware of the generic product specifications.
61 See Carrier & Minniti, How Mylan Hiked Prices, supra note 22, at 65; see also infra notes 69–74 and accompanying text.
Congress could consider replacing Section 505(q)(1)(E) with lan­guage emphasizing the filing of petitions within a reasonable time, with one year providing sufficient time to prepare a petition. One poten­tial statutory amendment (which includes a waiver for unusual circum­stances
62 One such circumstance could include the situation in which (1) a new study shows that a molecule is harmful in population X; (2) two years later, a different study shows that the molecule may also be harmful in population Y, which is similar to population X; and (3) a petition is then filed asserting that a generic should not be approved for treating population Y. It is arguable that a petition should have been filed two years earlier due to the similarities between populations X and Y. Allowing a waiver eliminates any ambiguity that could be used to reject the petition based on late filing.
) could provide:
505(q) petitions must be filed within one year of the petitioner learning of the safety or efficacy issue asserted in the petition. FDA may grant a waiver to allow later filing.
Such an amendment would make it more difficult to file questiona­ble petitions. And by focusing on the delay in filing, the analysis would pinpoint concerns based on timing, which raise red flags and can be dis­cerned, rather than the filer’s purpose or problems on the peti­tion’s face, which cannot readily be determined.
63 If challenged, the proposal should survive First Amendment scrutiny as a content-neutral restriction that (1) does not completely block petitioning and (2) serves an important government interest unrelated to the suppression of free expression in (a) solving a public health problem of consumers paying unwarranted monopoly prices from abusive petitions and (b) addressing the failure of prior efforts by the FDA and Congress to remedy the problem. See United States v. O’Brien, 391 U.S. 367, 377 (1968); see also supra notes 26–28 and 34–38 and accompanying text (discussing previous failures to find a solution). Previous widely acknowledged failures to solve the problem show that the recommendation “promotes a substantial government interest” that would otherwise “be achieved less effectively.” See United States v. Albertini, 472 U.S. 675, 689 (1985).
V. Address Resource Waste
A fourth proposal would require the FDA to disclose the money and time it expends resolving 505(q) petitions. In its Eighth Report to Congress, the FDA was “concerned about the resources required to respond to 505(q) petitions within the 150-day deadline at the expense of completing [its] other work.”
64 FY 2015 Report, supra note 26, at 8.
And in its Seventh Report, it explained that the reduction from 180 to 150 days “increased the strain on Agency resources,” which required it “to direct resources away from other important initiatives to attempt to comply with the new shorter deadline.”
65 FY 2014 Report, supra note 27, at 10.
Putting dollar and time figures on the resource drain from petition responses could offer important benefits. It would make the problems posed by citizen petitions more concrete and provide greater impetus for changes. As it stands now, the theoretical arguments based on freedom of expression and the possibility of raising legitimate concerns with the FDA, combined with inertia and the difficulty of limiting existing proce­dures, make it more difficult to impose limits on the process. Concrete figures depicting the resources expended on petitions, when considered in the setting of the overwhelming incidence of denials,
66 See supra note 18 and accompanying text.
could pave the way for changes.
VI. Promote Timeliness
Fifth, Congress could amend section 505(q)(1)(H) to require a peti­tioner to certify that it filed its objection within a reasonable time—say, one year—of discovering the claim that is the basis of the petition. Currently, the section requires the petitioner to certify that the petition includes “all information and views upon which the petition relies” and “representative data and/or information known to the petitioner which are unfavorable to the petition,” and that it took “reasonable steps to ensure that any representative data and/or information which are unfavor­able to the petition were disclosed.”
67 21 U.S.C. § 355(q)(1)(H) (2012).
The petitioner is also re­quired to “certify that the information upon which” the action requested is based “first became known” on a date the party specifies.”
Although it would appear that these requirements would result in peti­tions that are timely filed, that is not always the case. Petitioners sometimes file long after becoming aware of the basis for the petition. One example appears with Mylan’s citizen petition against Teva’s Epi-Pen alternative, filed on January 16, 2015.
69 Citizen Petition from Mylan Specialty, L.P., No. FDA-2015-P-0181-0001 at 1 (posted Jan. 20, 2015); see also Carrier & Minniti, How Mylan Hiked Prices, supra note 22, at 64.
In a development of which the industry would be keenly aware, Teva filed its ANDA against the Epi-Pen in 2008.
70 Larry Smith, The Promise of the Antares Pipeline is the Basis of My Buy Recommendation, Smith On Stocks (Jan. 25, 2012), http://smithonstocks.com/the-promise-of-the-antares-pipeline-is-the-basis-of-my-buy-recommendation-ais-2-40 [http://
perma.cc/4UJE-8B8B].
And court documents show that Teva produced its ANDA filing in the course of litigation on September 17, 2010.
71 Defendants’ Brief in Support of Their Motion to Dismiss at 6, King Pharm., Inc. v. Teva Parenteral Meds. Inc., No. 09-CV-652-GMS (D. Del. filed Dec. 13, 2010), 2010 WL 7583650.
This material included “detailed product descriptions, drawings, and instructions for use” for Teva’s proposed generic.
At the time (and to this day), Mylan (as distributor and marketer) was working hand-in-hand with Meridian/King (manufacturer), with the former taking over Orange Book sponsorship of the drug application and the latter targeting rivals in litigation.
73 Complaint at 2, King Pharm., Inc. v. Teva Parenteral Meds. Inc., No. 09-CV652-GMS (D. Del. filed Aug. 28, 2009), 2009 WL 2849496.
It thus seems exceedingly likely that Mylan would have been aware of Teva’s ANDA in 2008 and aware of documents explaining Teva’s product in 2010. In fact, it was Mylan that announced the settlement of the litigation, confirming its close connection to the case.
74 See Mylan and Pfizer Announce Epinephrine Auto-injector Settlement Agreement with Teva, Mylan (Apr. 26, 2012), http://newsroom.mylan.com/press-releases?item=123144 [http://perma.cc/V7EX-T49J].
This connection raises significant con­cerns that Mylan waited more than four years to file its citizen petition in 2015.
An amendment to section 505(q)(1)(H) to require a petitioner to certify that it filed its objection within one year of discovering the claim underlying the petition would help address the situation. The end of the section could include the following language:
The petitioner must certify that it became aware of the infor­mation upon which the action requested is based within one year of the petition.
Putting a timeframe on the obligation could make it more concrete and more difficult to evade. At the same time, one year should be enough time to research potential concerns with the generic drug. A certi­fication requiring filing within one year would make clear that peti­tions cannot be used to delay generic entry.
75 For an overview of the First Amendment implications of this proposal, see supra note 63 and accompanying text.
Citizen petitions have recently received attention as a tool by which brand firms have delayed generic entry, allowing them to maintain their monopolies and preventing consumers from enjoying lower prices. The FDA has revealed concern with the resources it expends on petitions and has recently denied nearly all petitions targeting generic entry.
The five proposals offered in this Piece would address the most egre­gious aspects of the process. They would increase transparency, allow the dismissal of frivolous petitions, and prevent some of the most flagrant instances of delayed generic entry. Given high drug prices, the five pro­posals are worth attention.