Competitive Downsides from Off-Label Promotion

Transcription

1 Competitive Downsides from Off-Label Promotion IIR Conference on Off-Label Marketing June 26, 2001 William W. Vodra Arnold & Porter th Street, N.W. Washington, D.C (202) June 26, 2001 Arnold & Porter 1

2 Basic Legal Principles Off-label promotion claims protection under the First Amendment Congress shall enact no restrictions on freedom of speech Commercial speech doctrine does not protect any speech that is false or misleading Any regulation must advance legitimate public purpose without excess June 26, 2001 Arnold & Porter 2

3 Washington Legal Foundation Principles Dissemination of reprints and textbooks, and sponsorship of CME programs, is commercial speech. None of the following is inherently false or misleading: Reprints from peer-reviewed journals Independently written and published textbooks CME programs produced by ACCME-accredited group June 26, 2001 Arnold & Porter 3

4 Washington Legal Foundation Principles Regulation of off-label promotion serves a public purpose Public has an interest in getting new indications into approved labeling Public interest in assuring physicians have FDA-approved materials only is not sufficient for regulation FDA regulation furthers that purpose June 26, 2001 Arnold & Porter 4

5 Washington Legal Foundation Principles FDA regulation of reprints, texts, and CME programs is excessive FDA should consider other approaches than suppression of these activities Congress should have tried other, lesser restrictive approaches than FDAMA June 26, 2001 Arnold & Porter 5

6 Many Open Issues after WLF The reasoning is not limited to the three special cases described (reprints, texts, and CME programs meeting the court s definitions) Other speech can be true and non-misleading Legal incentives to encourage research by limiting competition serve a public purpose Courts have not assessed these laws June 26, 2001 Arnold & Porter 6

7 The Usual Off-Label Debate FDA is preventing companies from disseminating off-label information that physicians and patients need to use drugs most effectively. Government is the villain Companies are the well-meaning victims Consumers, prescribers, and purchasers are injured bystanders June 26, 2001 Arnold & Porter 7

8 Another Off-Label Debate We spent a fortune proving to FDA that our product is safe and effective for this indication. And now our competitor is taking market share, without proving anything. Another company is the villain Your company is the well-behaved victim Consumers, prescribers, and purchasers are injured bystanders Can the company protect its investment? June 26, 2001 Arnold & Porter 8

9 Intellectual Property Protections Government confers rights to exclude others from the use of `intellectual property. Patents covering method of using a drug Hatch-Waxman restrictions on ANDAs for new uses Orphan Drug Act exclusivity for specific uses Can these laws block off-label promotion? June 26, 2001 Arnold & Porter 9

10 Patent Laws Private right of action in patent holder to sue an alleged infringer Remedies include monetary damages and injunctions Usually injunctions are prohibitory ( Thou shall not. ) May include mandatory actions ( Thou must do. ) June 26, 2001 Arnold & Porter 10

11 Patent Laws Patent laws are intended to advance scientific knowledge WLF decisions do not speak to the use by private parties of off-label speech to prove patent infringement Although executive branch of government is not suppressing speech, a finding of infringement could involve the judicial branch in censorship June 26, 2001 Arnold & Porter 11

12 Hatch-Waxman and Orphan Drug Protections Intended to encourage research and incorporation of new indications into labeling Both protections incorporated into Federal Food, Drug & Cosmetic Act No private right of action; competitors cannot sue each other under FFDCA FDA can only take action for marketing a new drug without approved NDA June 26, 2001 Arnold & Porter 12

13 Hatch-Waxman and Orphan Drug Protections WLF argues that FDA cannot rely on certain materials as evidence of marketing with approved NDA If correct, then FDA might not be able to enforce Hatch-Waxman and Orphan Drug provisions In addition, WLF decisions say that FDA cannot suppress speech in order to get information into approved labeling June 26, 2001 Arnold & Porter 13

14 Lanham Act Federal law that permits competitors to sue each other for false or misleading promotion Has been used in several alleged offlabel cases Zeneca and Barr Labs v. Lilly (Evista) Schering v. Pfizer (Zyrtec) Each case involved claims that had been rejected by FDA June 26, 2001 Arnold & Porter 14

15 Lanham Act Open question whether Lanham Act is limited by First Amendment By definition, it applies to false or misleading promotional claims, which are not protected under the Commercial Speech Doctrine WLF court found some materials and activities not inherently misleading, but could they still mislead? June 26, 2001 Arnold & Porter 15

16 The Role of 3rd Party Payers If company cannot protect itself by lawsuit against an off-label competitor, can it block coverage by 3rd party payers? Private insurers -- contract law Government programs subject to courts Pfizer v. VA -- held VA could limit formulary to one drug in class, even though that drug had fewer approved indications than another June 26, 2001 Arnold & Porter 16

17 The Role of Physicians If company has no direct protection, can physicians give preference for on-label products over off-label ones? Perception that all claims are approved by FDA Disclaimers only meaningful against this perception Disclaimers/notice given only to physicians Formulary restrictions may control June 26, 2001 Arnold & Porter 17

18 The Role of Patients Can patients give preference for onlabel products? Lack of notice of off-label status Issues of informed consent, learned intermediary Opportunity to participate in product selection Issues of insurance coverage, formulary restrictions Exposure to different risks June 26, 2001 Arnold & Porter 18

19 The Role of Patients Product liability suits can be filed, if injury can be proven More likely when patient suffers side effect unique to off-label drug than when there is a failure of efficacy Suits without physical injury may also be possible under state unfair trade practice and consumer protection laws June 26, 2001 Arnold & Porter 19

20 The Role of Patients In 1998, FDA sent Pfizer a Warning Letter asserting that Zoloft had been promoted for long-term use, use in women, and use in varieties of depression, without the information in the labeling Suits filed in TX and CA on behalf of all patients prescribed Zoloft for unapproved indications June 26, 2001 Arnold & Porter 20

21 The Role of Patients Subsequent to the Warning Letter, FDA revised Zoloft labeling based on information in the original NDA Suits were later dismissed without court rulings Potential field for class action plaintiffs bar June 26, 2001 Arnold & Porter 21

22 The Ironical Role of Patients WLF litigation started from belief that patients were deprived of benefits of the most current knowledge about drugs In the end, it may be patient advocates (class action lawyers) who have the most influence in preventing dissemination of off-label information June 26, 2001 Arnold & Porter 22

23 Summary A company that gets a claim approved in its labeling cannot may have limited ability to protect its investment FDA may not be able to enforce exclusivity provisions Limits of patent laws and Lanham Act not tested 3rd party payers may select any products they wish June 26, 2001 Arnold & Porter 23

24 Summary Currently, physicians and patients have little or no practical ability to prefer onlabel to off-label products 3rd party payers could show preferences, but their interests lie principally in controlling costs, not rewarding innovation Thus, the on-label competitor may get little benefit from its investment June 26, 2001 Arnold & Porter 24

25 Can Congress Find New Incentives? WLF court suggested that Congress find new ways to reward innovation Pediatric exclusivity has been very effective, but it (like Hatch-Waxman and Orphan Drug exclusivity) requires FDA to enforce it Can tax incentives or cash grants be a substitute? June 26, 2001 Arnold & Porter 25

26 Conclusion and Discussion June 26, 2001 Arnold & Porter 26