In order to protect the health of Americans, approval of new prescription drugs for market and on-going monitoring must be devoid of influence from drug manufacturers and prescription drugs must be affordable for all who need them.
To achieve these objectives, the following 10 principles must be adopted through new regulations or new law and overseen by an independent commission charged with protecting the interests of the public.
Approval & Monitoring of Prescription Drugs
The FDA should only approve new prescription drugs if the following requirements are met:
1. Clear evidence is provided demonstrating safety and efficacy;
2. The pharmaceutical meets the standard of being a truly new agent, not simply a biochemical manipulation designed to extent a patent, and is deemed to better than any other approved drug of similar design or provides a similar medical benefit at a lower price;
3. Adequate clinical trials have been conducted in sufficient number and over adequate time to reach scientifically secure conclusions. This information must be released to the public.
Already approved drugs must be monitored and pharmaceutical marketing practices scrutinized:
4. Systems must be established to ensure that unforeseen side effects of approved drugs are detected in a timely fashion;
5. All individuals who contact physicians on behalf of drug manufacturers or marketers must be licensed. This licensing should include a fee to pay for increased oversight of the industry and provide for the revocation of a license if prescription drug health risks are not disclosed;
6. New standards must be developed to police fraudulent or misleading prescription drug marketing and physician detailing.
Conflict-of-Interest Standards
To ensure FDA, NIH and other oversight agencies are devoid of the pharmaceutical industry financial influence:
7. Individual compensation will exclude any and all monies or other financial gains derived from any activity performed by regulators on behalf of the pharmaceutical industry and biotech industry. This will include research, lectures, consults and any and all other activities paid for, directly or indirectly by the pharmaceutical industry or any company involved in the production of pharmaceutical agents or other products monitored, approved or otherwise regulated by any agency by which the individual is employed. Investments in the pharmaceutical industry or any company involved in the production of prescription drugs are other products will be limited to $5,000 per individual.
8. Regulators may not accept employment from formerly regulated entities for 5 years.
Guarantee Affordability
9. New standards must be developed to allow greater access to generic equivalents;
10. A U.S. bulk purchasing pool that negotiates discounts from drug makers should be open to all Americans.
