Manufacturer Sponsored Speech

Transcription

1 Manufacturer Sponsored Speech Legislative, Regulatory and Alan R. Bennett March 22, 2016 Agenda Why Now? Major Areas of Dispute Current Developments - FDA - Judicial - Legislative Summary of Trends 1

2 WHY NOW? Promotional System designed in 1970s for 1970s conditions: - Limited technology - Sales rep often only source of info for doctors - No right of commercial free speech - Geared entirely to regulating company-prescriber communications WHY NOW? Huge Changes in Landscape: - More institutional health care actors (payers, PBMs, formulary committees, etc.) - Explosion in availability of information, some good, some not - Developments in First Amendment Law - Can t ignore government enforcement cases. 2

3 Major Areas of Dispute Payer Communications - FDAMA Other payer communications/pre-approval discussion Scientific Exchange Definition of labeling (and advertising) Substantial Evidence Standard for Claims (including onlabel claims) Intended Use Existing Guidelines - USRs - Textbooks and CPGs Developments at FDA-Policy Response to MIWG Citizen Petition #2 (June 6, 2014) Petition granted insofar as it requests greater clarity and asks FDA to address (1) unsolicited requests, (2) Scientific exchange and off-label communications, and (3) communication of PE data to payers. Agency promised further guidance by the end of 2014; subsequent letter extended this deadline to first half of

4 Developments at FDA-Policy April, Promise of Public Hearing by summer 2015 on speech issues hasn t been mentioned in 9 months. Guidance Development Off Label/Scientific Exchange Draft was completed late last fall. Sent to HHS for sign off, but rejected, apparently by HHS GC s office Also had been far along in drafting FDAMA 114/Payer guidance, but went back to drawing boards. Developments at FDA-Policy FDA Regulatory Agenda 2016: includes both off-label/scientific exchange and payer communications guidance. Guidance on New Risk Information (6/14) Permits use of data other than substantial evidence to update safety information on the label Draft removal of knowledge prong of intended use regulation (21 CFR ); done in context of tobacco regulations but applicable across the board. 4

5 Developments at FDA-Enforcement Fewer Warning and Untitled Letters 2015: Only 9, none really targeting unapproved new uses 2016: Only 1 so far, unrelated to off-label/new use issues Retraction of Pacira Letter (Discussed more fully in litigation section) Broadly written indication not limited to data in pivotal trials; use of substantial evidence studies that fall within the broad indication permitted. Amarin Decision -Company attempted to use adequate and well controlled study on reduction of triglycerides in new (sub)population. Although study met endpoints, FDA didn t believe reducing triglycerides in this subpopulation had clinical significance. -Dietary supplement (same active ingredient) could make same claim Amarin wanted to make, accompanied by disclaimer. 5

6 Amarin (cont d) First Amendment protects all truthful non misleading off-label speech, including proactive statements made by a manufacturer. Truthful, non-misleading off-label speech by itself cannot be the act that constitutes a violation of the FDCA Found FDA to be enforcing against speech itself without allegations of non-speech wrongdoing Court spent considerable energy crafting specific disclaimers Worth considering whether FDA is being replaced as regulator by the courts, and the impact of judicial involvement Court encouraged voluntary consultation with FDA 6

7 Pacira v. FDA (SDNY 2015): Exparel approved to relieve post-surgical pain Directions for use describe infiltration into surgical site, chart for bunionectomy and hemorrhoidectomy FDA Warning Letter for promoting use of Exparel for infiltration in other surgical sites and for comparative durational claims between Exparel and pain pumps APA and First and Fifth Amendment challenge FDA withdraws Warning Letter and issues revised label clarifying Exparel may be used in other surgical sites and scientific evidence re duration of effect also permissible US v. Vascular Solutions Inc. (WDTX 2016): Company and CEO indicted for misbranding for lack of adequate directions for use DOJ alleged VSI produced Short Kit version of Vari- Lase product to treat veins that were outside of FDA approval Court charged jury: It is not a crime for a device company or its representatives to give doctors wholly truthful and non-misleading information about the unapproved use of a device. If you find that VSI s promotional speech to doctors was solely truthful and not misleading, then you must find the Defendants not guilty of the misbranding offense. Jury acquitted 7

8 US v. Facteau (D.Mass. 2016) (ongoing): Executives of Acclarent charged with misbranding as well as securities and wire fraud Allegation that company obtained FDA clearance for sinus spacer for use with saline, but sole intended use was to deliver steroid to the sinuses In opposition to motion to dismiss, DOJ emphasizes allegations that speech was false or misleading, while continuing to argue that speech is only being used as evidence of crime, not the crime itself Legislative Developments 21 St Century Cures (H.R. 6) Considered a number of speech related issues Ultimately passed bill with two relevant provisions: FDAMA 114 clarified; HCEI broadened to make clear inclusion of clinical data inputs, clinical and other assumptions, so - no need for comparative clinical trials - info must relate to approved indication - some broadening of audience to payers with expertise in analyzing PE data - Need for FDA intervention questionable at best FDA to develop draft guidance on off-label communications within 18 months of passage of legislation. Leaves implementation to FDA Draft guidance rather than regulation 8

9 Legislative Developments Senate-Innovation legislation does not have specific provisions dealing with speech issues; allegedly due to opposition from Administration. Senate moving a package of narrow legislation not dealing with speech. Some possibility of FDAMA 114 fix, but much uncertainty. Question is what happens when House and Senate work out their differences? Lilly-Anthem Proposal Would permit pre-approval discussions with payers with respect to safety, efficiency and PE information for drugs in FDA review process. Goes beyond existing FDAMA 114 fixes in that it deals with pre-approval (off-label) issues. Summary FDA under increasing pressure from stakeholders and courts to re-evaluate its promotional policies, most of which date to the 1970s. Internal disagreements at the agency make change difficult, but should expect draft guidances on off-label/scientific exchange, and payer communications this year. 9

10 Summary Cases like Caronia and Amarin making current system increasingly untenable. Courts driving to a system whereby all speech, including promotional speech, is permissible, as long as truthful and non-misleading and accompanied by adequate disclosures. Does that system make sense? At the same time, increasingly difficult to obtain convictions, especially where individuals are charged and there is no patient harm. Summary Congress unlikely to take this issue on in current legislative session; possibly PDUFA? Possibility remains that litigation could unexpectedly bring down entire regulatory scheme would be optimal if FDA and stakeholders could work something out that would pass constitutional muster before that happens. 10

11 Ask 11