1. The Physicians Proposal for a National Pharmaceutical Program
PNHP Annual Meeting 2016
Adam Gaffney, MD
David Himmelstein, MD
Joel Lexchin, MD
Gordy Schiff, MD
Enrique, Seoane
Steffie Woolhandler, MD

2. Problems of the Pharmaceutical System, US and Canada
Inadequate access
Clinical Testing
Uninsurance
Industry distortion of results, conduct, presentation.
Drug copayments/cost sharing
Data secrecy
Preclinical Development
Drug Approval
Lack of innovation: “me-too” drugs.
Regulatory agencies mission corrupted: user fees
Patent abuses.
Expedited reviews  less safe drugs.
Public R&D funding > Private profits

3. Problems of the Pharmaceutical System, US and Canada (continued)
5. Postmarketing/Safety
Sluggish fulfillment of postmarketing studies.
Inadequate funding of safety programs at regulatory agencies.
6. Promotion
Misleading advertisements
Wasted resources
Inadequate review of promotional materials.
Drug spending
Much higher than other OECD nations.

4. I. Access and Provision Comprehensive pharmaceutical benefit for all.
Elimination of Drug-Cost Sharing

5. II. Preclinical Drug Development
Repeal of Bayh—Dole: Drugs developed in publicly-funded labs would not be eligible for patent protection.
Drug development “public track”
NIH “Drug Innovation Division”: Fund R&D of new drugs in noncommercial laboratories; new drugs would be in the public domain.
Public track would be geared to neglected diseases, commercially unprofitable diseases, untreatable diseases, etc.
Patent Reform
Not able to patent clinically equivalent isomers, minor changes to drug delivery devices.

6. III. Clinical Testing Improve clinical trial standards
Default: compare new drugs to efficacious comparators.
Default: Hard endpoints, not surrogate endpoints
Data Transparency
Trial data (anonymized) will be publicly available, both for drugs that receive marketing authorization and those that do not.
Clinical trial funding reform
Most clinical trials will be publicly funded.
NIH Division of Clinical Trials will select drugs to be tested; actual trials performed extramurally.
Also test new uses for old drugs.

7. IV. Drug Approval Reform
Full FDA/Health Canada public funding.
Narrowed eligibility for expedited approval.
Increase in regulatory agency resources.

8. V. Postmarking Studies and Safety Monitoring
Postmarketing studies: Enforce requirement that companies perform required postmarketing studies in the appropriate time period.
Drug safety funding: Branches of regulatory agency responsible for drug safety should have similar levels of funding as those for drug approval.

9. VI. Promotion
Increased funding for regulatory agency review of promotional materials.
Increased, escalating sanctions for misleading sanctions.
Continued Medical Education: not industry funded.
DTC Advertising (US)
Optimally banned, although this could be unconstitutional.
Conceivably, single payer could exclude drugs promoted via DTC from national formulary.
Tax Reform
No more tax writes off for money spent on promotion.

10. VII. Lowering Drug Costs
Increase proportion of generic/public domain drugs
Especially from NIH Drug Innovation Division
Also end of Bayh-Dole and patent reform.
Direct drug negotiations with a national formulary.
Compulsory Licensing
If singe payer unable to negotiate a reasonable price with a company (defined as guaranteed rate of return over costs of R&D/production) for a patented drug, would issue a compulsory license to generic manufacturer.
Public production
Last resort when unable to obtain a reasonable price with a generic manufacturer, or during shortages and public health emergencies.

11. VIII. Savings (preliminary US estimates).
-$157.2 billion
Reducing non-discounted drug spending to OECD averages/approximate prices (50%).
$22 billion
Increased drug spending on the uninsured
$34.9 billion
Increased drug utilization by eliminating copayments (17% utilization increase)
$54.8 billion
New Public R&D Costs
$3.2 billion
New regulatory agency costs
-$42.3 billion
Potential annual net savings

12. Questions/Discussion