Prescription for Pharmaceutical Reform: Healing an Ailing System

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

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)

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: https://doi.org/10.1136/bmj.k1039 (Published 17 May 2018

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: https://doi.org/10.1136/bmj.k1039 (Published 17 May 2018

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

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

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

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