1. Prescription for Pharmaceutical Reform: Healing an Ailing System

2. Six Principles of Reform
Access
Medical needs, not finances, should determine access
Affordable
Drugs must be affordable to society
Innovation
Apply innovation to maximizing population health
Health first
Health must take precedence over patents
Well tested
Medications independently and rigorously evaluated
Honesty
Comprehensive and unbiased information
BMJ 2018;361:k1039
BMJ 2018; 361 doi:  17 May 2018

3. Guarantee Access to Prescription Drugs
Establish a national formulary
Provide all residents with full coverage of formulary drugs
Eliminate copays and other cost-sharing
Millions of Americans
are unable to access
prescription drugs because of high out-of-pocket costs
BMJ 2018;361:k1039
BMJ 2018; 361 doi:  17 May 2018)

4. Lower Drug Prices Negotiate with patent holders
Compel price gougers to license their patents to generic manufacturers
When necessary, allow for public production of critical drugs
Our drug prices are rising
far beyond the cost of development and production
BMJ 2018;361:k1039
BMJ 2018; 361 doi:  17 May 2018

5. Reform Our Drug Development Process
Deny patents for trivial changes; limit market exclusivity to clinically superior drugs
Publicly fund and supervise the majority of clinical trials
Use public agencies to develop new, non-patented drugs
Keep publicly funded research in the public domain
Today’s patent process keeps prices high and discourages innovation by rewarding minor tweaks.
BMJ 2018;361:k1039
BMJ 2018; 361 doi:  17 May 2018

6. Independent Clinical Testing
Publicly fund the majority of clinical trials
Higher standards for approvals
Increase transparency of data
Implement strong monitoring after drugs reach the market
Most clinical trials
are now conducted by
private drug firms
that own the data and
hide safety concerns.
BMJ 2018;361:k1039
BMJ 2018; 361 doi:  17 May 2018

7. Tighten Our Drug Approval Process
Fully fund regulators with public money, not industry user fees
Less frequent use of dangerous “expedited reviews”
Restrict regulatory advisory committees to experts without financial ties to drug companies
Drug manufacturers
now fund the FDA.
Regulators now often allow
unsafe drugs onto market.
BMJ 2018;361:k1039
BMJ 2018; 361 doi:  17 May 2018

8. Post-marketing Surveillance
Increase funding and authority for regulatory agencies’ post- marketing monitoring programs
Enforce requirements to promptly perform post-marketing studies
Regulators neglect to monitor safety and efficacy after approval
BMJ 2018;361:k1039
BMJ 2018; 361 doi:  17 May 2018

9. Ensure Honest Communication
Fund regulatory review of ads
Penalize misleading promotions
Eliminate tax deductions for advertising
Prohibit drug firms from funding education and guidelines
Drug firms spend billions on marketing but are poorly monitored.
BMJ 2018;361:k1039
BMJ 2018; 361 doi:  17 May 2018