Class Nine/notes

From Cyberlaw

Notes 4.10.06

Relationships w/ Health Care Providers and Conflicts of Interest

Bruce A. Leicher

Note: today's slides were v thorough, so these are just additional notes:

Research:

• BoD: why is university faculty so special?

Human Subject Research:

• Informed consent: what info does market need? What gets disclosed?

Relationship w/ PhRMA:

• Continuing Medical Edu: if not PhRMA, who will fund? Compare to other industries (e.g. CLE)

• Promotion of Products: pharm companies can track who prescribes drugs and how much

Hot Buttons:

• Off-label sales: why are they being promoted?

• Financial support: if payments not at FMV, it’s fraud/bribe

Each one of the recent enforcement actions was started by whistleblower

• Gets up to 25% of proceeds

• Why don’t they go to trial? Ppl are terrified of being de-barred

Pfizer case:

• If doctors are working for your company and plan to go to physician offices to get them to consider off label use, that’s inducement, i.e. criminal

• Hard to find a comfortable line

• 1st A problem? It’s corporate behavior – does that matter?

• Motive was increasing prescriptions, not research, i.e. kickback bc inducing doctors to make false claims

o It was a plan – used publication to get drug sold, avoided registration consciously

FDA only regulates the sale and marketing of drugs by pharmaceutical companies

You’re not allowed to submit a claim unless FDA approved. Can you distribute a study?

• FDA says it follows its regs, not Constitution

• USAO varies:

o Some say if truthful and not misleading and not accompanied by anything that would be a bribe/kickback, then okay – falls w/in 1st A protection

o Others say if you put a sticker on it saying everything ab the article to make it not misleading (i.e. not approved for this use), then okay

• No definitive court ruling on this

o Industry mainly stickering articles w/ instruction that sale force not discuss the articles

PhRMA Code is floor for compliance

• Prosecutions in 90s were easy bc the practices were so bad – once you realized you could use False Claims Act, easy to prosecute

• V strong code for industry to have come up w/

o Female salesppl didn’t like how no more family dinners bc awk to invite male doctors to dinners alone

Recent Investigations:

• How much are you paying?

• Where are you holding meetings? What part of country, what kind of hotel?

• How many advisory boards do you need?

• Best price: discounts should be going to govt

Accredited CME won’t even let you say who the speakers are

Hypo 1: do you feel comfortable asking your dr if he switched bc of kickbacks?

• Urologists and oncologists make money off the drugs they prescribe

Hypo 2:

• Spokesperson/salesman distinction?

• Does this give the impression the PI is tainted?

• Is his research done – then he can speak as an expert?

Belee 23:40, 10 April 2006 (EDT)