Emerging Issues: Challenging AntiGenerics Legislation Whats old is new again'

1
Emerging Issues Challenging Anti-Generics
LegislationWhats old is new again.

• Bryan R. OMalley
• Assembly Member Richard N. Gottfried
• Chair, Assembly Committee on Health
• New York State Assembly

2
New Yorks Generic Substitution Law

• If a cheaper generic that is equivalent exists,
  the pharmacist must dispense that
• One Exception If a prescriber writes DAW or
  Dispense As Written
• Exception applies for brands and generics

3
Whats Pending

• A.9303 (Aubry)/S.5016 (Hannon)
• Exempts anti-epileptic drugs from the state
  mandatory generics substitution law
• Requires practitioner permission before a generic
  is substituted for a brand name medication
  reverses the presumption for substitution
• Creates loophole that is much larger than intent

4
What is an anti-epileptic drug

• Any drug prescribed for the treatment of epilepsy
  
• Or
• A drug used to treat or prevent seizures

5
The Argument For

• Patient Safety
• Therapeutic substitution of anti-epileptic
  medication may result in an improper dosage,
  decreased efficacy, life-threatening toxicity, or
  adverse interaction with other drugs. (Memo of
  support from Harter Secrest and Emery LLP on
  behalf of GlaxoSmithKline)
• Almost 15,000 people in New York with epilepsy
  would have a breakthrough seizure with a
  formulation change. (Epilepsy Foundation Memo of
  Support for A9303, emphasis added)

6
The Argument For

• Cost avoidance
• although mandatory substitution to less
  expensive drug products could cut pharmacy costs
  in the short run, in the long-term the costs of
  mandatory substitution could be far higher.
  (Memo of support from Harter Secrest and Emery
  LLP on behalf of GlaxoSmithKline)
• Complications caused by therapeutic substitution
  can result in additional health care expenditures
  such as, (sic) added physician visits and/or
  hospitalizations. (Memo from Davidoff, Malito
  and Hutcher to Assembly Member Gottfried, dated
  3/16/2007, on need for mandatory generic
  exemption for anti-epilepsy drugs)

7
The Argument For

• Its not even the same drug!!!
• According to the General Pharmaceutical
  Association, When a product is therapeutically
  substituted, the patient is receiving an entirely
  different drug. (Memo from Davidoff, Malito and
  Hutcher to Assembly Member Gottfried, dated
  3/16/2007, on need for mandatory generic
  exemption for anti-epilepsy drugs)

8
History is a vast early warning system. -
Norman Cousins
9
The year was 1977

• Mandatory generic law passed

10
The Argument Against

• Patient Safety
• This legislation poses a potential threat to the
  health of every New York resident who receives a
  substituted prescription. (Hoffmann LaRoche Memo
  in Opposition provided to Governor Carey while he
  considered the legislation)
• This legislation is not a simple pro-consumer
  measureit is potential consumer health as well
  as political dynamiteand folly for the New York
  Legislature to fly in the face of overwhelming
  available evidence... (Empire State Chamber of
  Commerce in Memo of Opposition to Governor Hugh
  Carey)

11
The Argument Against

• Its not even the same drug!!!
• The blithe assumption of generic equivalence
  is simply wrong. (Empire State Chamber of
  Commerce Testimony on Generic Drug Substitution
  Bill, April 28, 1977)
• It is our position that while prescribing or
  dispensing drugs by generic name neither conveys
  nor impugns product quality, it does mandate
  anonymity and that there are, in fact,
  differences in drug product quality. (Memorandum
  Requesting Executive Disapproval, American Home
  Products Council, July 19, 1977)

12
The year was 1997

• Coumadin (DuPont-Merck) faces generic competition
  from Barr Pharmaceutical, who produces generic
  Sodium Warfarin
• Assembly Member Steve Sanders introduces
  legislation to exempt Narrow Therapeutic Index
  (NTI) drugs from the Mandatory Generic Law

13
The Argument For

• Patient Safety
• The critical difference with respect to (NTI)
  drugs is that, unlike the many other drugs, a
  small change in the level of the dosage, a small
  change in the component parts of that drug can
  have a profound impact on that patient and the
  services being provided to that patient.
  (Testimony of Assembly Member Steve Sanders)
• Our research demonstrates that the implications
  to the health of New Yorkers is large when
  considering a substitution for anti-coagulation
  drugs739 strokes, 146 deathsThats comparable
  to a major disaster like an airplane crash.
  (Testimony of Dr. Frederick Munschauer,
  Neurologist and Internist, SUNY Buffalo)

14
The Argument For

• Cost Avoidance
• The risks of adverse reactions, including the
  loss of seizure control and the development of
  toxic side effects associated with the mandatory
  substitution of generic anti-epileptic drugs can
  be avoided. (Testimony of Jessica Goldsmith,
  Epilepsy Society of New York)
• When NTI drugs are switched to generics, there
  is usually an immediate cost of retitrating and
  stepped-up monitoring of the patient, and there
  may be even greater costs if there are medical
  complications because of substitution of NTI
  generics higher costs for more doctors visits,
  if not even visits to an emergency room, if not
  even hosptializations. (Testimony of Mark
  Green, Former Public Advocate for the City of New
  York)

15
The Argument For

• It is not even the same drug!!!
• Well, Im concerned about the FDAs statements
  that they can assure that every batch of an NTI
  drug thats manufactured by different companies
  is going to be the same. We all use different
  materials. We all use different suppliers.
  (Testimony of Richard Davis, DuPont-Merck)

16
The FDA (or) The Argument Against

• Weve watched this closely (adverse events
  reporting of Coumadin and Sodium Warfarin), we
  are watching it closely now, and we do not see
  anything from marketplace adverse event reports
  that signals a problem with the multi-source
  products.
• FDA does not distinguish for the benefit of the
  practitioner that some drugs should be
  distinguished based on Narrow Therapeutic Index
  for quality characteristics. Its a very
  critical distinction. We believe that all our
  approaches control the quality of the drug, so
  that the innovator and the generics may be
  exchanged under the conditions of use.
• (Testimony of Dr. Roger Williams, Deputy
  Director, Center for Pharmaceutical Science, Food
  and Drug Administration)

17
New Evidence (or)The Argument Against

• JAMA No difference between brand and generic
  cardiovascular drugs, including those in NTI
  classes.
• Kesselheim, et al. Clinical equivalence of
  generic and brand-name drugs used in
  cardiovascular disease A systematic review and
  meta-analysis. Journal of the American Medical
  Association. 12/3/2008.

18
Clinical Literature

• 11 articles studied Warfarin/Coumadin
• 6 prospective studies the generic performed
  similar with respect to clinical endpoints such
  as number of required dose adjustments and
  adverse events
• 5 retrospective studies - evaluated outcomes
  using pre/post test design and found no clinical
  outcome differences
• 1 found small but clinically significant decrease
  in INR in patients, but no increase in morbidity
  or mortality
• 1 retrospective study found increased health care
  utilization, but the comparator was not rated
  bioequivalent by FDA

19
Editorial Literature

• 18 editorials focusing on NTI cardiovascular
• 12 expressed negative view of substitution
• 4 supported substitution

20
What Explains the Difference

• Editorials reflect anecdotal evidence, not
  clinical knowledge
• Conclusions biased by unreported financial
  relationships with brand name pharmaceutical
  companies
• Kesselheim, et al. Clinical equivalence of
  generic and brand-name drugs used in
  cardiovascular disease A systematic review and
  meta-analysis. Journal of the American Medical
  Association. 12/3/2008.

21
Major Finding

• Our results suggest that it is reasonable for
  physicians and patients to rely on FDA
  bioequivalence rating as a proxy for clinical
  equivalence among a number of important
  cardiovascular drugs, even in higher-risk
  contexts such as the NTI drug warfarin.
• Kesselheim, et al. Clinical equivalence of
  generic and brand-name drugs used in
  cardiovascular disease A systematic review and
  meta-analysis. Journal of the American Medical
  Association. 12/3/2008.

22
Historys lesson

• The same themes always arise
• Anecdotal evidence is used in place of scientific
  evidence
• Scientific evidence is on our side

23
Applying History to A.9303

• Despite heart-wrenching anecdotes, patient safety
  is not at risk
• 30 years of DAW shows generics reduce costs to
  patient and system
• If practitioners want brand, they can write DAW

24
Bryan R. OMalleySenior Legislative
AssistantAssembly Member Richard N.
GottfriedChair, New York Assembly Committee on
Health 518-455-4941 omalleb_at_assembly.state.ny.us