Prescription for Pharmaceutical Reform: Healing an Ailing System

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: https://doi.org/10.1136/bmj.k1039 (Published 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: https://doi.org/10.1136/bmj.k1039 (Published 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 farbeyond the cost of development and production BMJ 2018;361:k1039 BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1039 (Published 17 May 2018

5. Reform Our Drug Development Process • Deny patentsfor 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: https://doi.org/10.1136/bmj.k1039 (Published 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: https://doi.org/10.1136/bmj.k1039 (Published 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: https://doi.org/10.1136/bmj.k1039 (Published 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: https://doi.org/10.1136/bmj.k1039 (Published 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: https://doi.org/10.1136/bmj.k1039 (Published 17 May 2018