Concrete suggested reforms of FDA processes

hari kumar

This is by Adam Gaffney & Joel Lexchin:

"Our proposal rests on six principles:

• Medical needs, not financial means, should determine

access to medications

• Drugs must be affordable to society

• Drug development should be geared toward real innovation

that maximizes population health

• The human right to health16 must take precedence over

intellectual property rights (patents)

• The safety and effectiveness of medications must be

independently and rigorously evaluated

• Comprehensive and unbiased information on drugs should

be available to prescribers and patients."

There are some more concretes (Box 1):
"Box 1: Summary of proposed pharmaceutical reforms

1.Access to prescription drugs

• Each nation would establish a formulary of all medically necessary prescription drugs

• If agents with equivalent efficacy and safety were available, only the least expensive would be included

• All residents would have full coverage for all formulary medications without copayments, co-insurance, or deductibles

• When clinically necessary (eg, allergies), non-formulary alternatives

would be covered

2. Drug prices

• Government would negotiate with drug firms to lower prices

• “Compulsory licensing” would allow generic manufacturers to produce essential patented medications if the patent holder refused to offer a reasonable price

• Government would commission public production of essential drugs when price negotiation fails and no reasonably priced generic is available

• New public divisions of the NIH and CIHR would develop non-patented drugs and make them available for low cost generic manufacture.

3. Preclinical drug development

• Preclude patents for trivial modifications of existing agents, and restrict market exclusivity for me-too drugs unless they are shown to be more effective or convenient or have fewer side effects than others in the same class.

• Repeal provisions of the Bayh-Dole Act in the US that allow private firms to obtain exclusive licenses for drugs developed through publicly funded research

• Establish public drug innovation divisions in the US and Canada that would fund and oversee the early stages of drug development

4. Clinical testing

• Require higher standards for clinical trials used in drug approval applications

• Increase the transparency and public availability of (anonymized) clinical trial data

• Publicly fund the majority of clinical trials through new “Clinical TrialsDivisions” of the NIH and CIHR.

5 Drug approval reform

• Full public funding of the drug regulatory agencies, ending their reliance on industry user fees

• Less frequent use of expedited reviews

• Restrict membership on regulatory advisory committees to experts without financial ties to drug companies

6. Postmarketing surveillance

• Enforce requirements to promptly perform postmarketing studies

• Increase funding and authority for regulatory agencies’ postmarketing monitoring programs

7. Promotion

• Ensure that regulatory agencies have adequate resources to review promotional materials

• Stiffen sanctions for misleading drug promotion

• Eliminate tax deductions for expenditures for direct-to-consumer advertising and other marketing and, in some cases, exclude advertised drugs from the formulary

• Promote academic detailing in lieu of industry detailing

• Reduce the role of industry funding in continuing medical education and guideline development


"At BMJ: 'Healing an ailing pharmaceutical system: prescription for reform for United States and Canada. BMJ 2018;361:k1039 doi: 10.1136/bmj.k1039 (Published 17 May 2018)  (If anyone needs please write off-line).
Hari  PS: I fear the formatting of messages here is a matter that I cannot seem to control, as it has a mind of its own..!  Sorry. Les if I need remedial teaching show me how...!

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