It is good to read the research article “Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study”.
Expedited approvals for new drugs include, “Accelerated approval pathway”, “Breakthrough therapy”, “Fast track designation”, and “Priority review”. The Food and Drug Administration (FDA) initiated “Accelerated approval regulations” in 1992, and the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 2012 allowed the FDA "Accelerated approval for the drugs for serious conditions" with an unmet medical need, based on a surrogate marker or an intermediate clinical endpoint; it also included “Breakthrough therapy”[1,2]. FDA designed a “Fast track process” to facilitate the development, & a “priority review” for faster review within six months (compared to 10 months under standard review) [3,4].
Drug companies must conduct a “confirmatory trial” once the drug is on the market in an accelerated approval program and the FDA must take appropriate action regarding its approval if the drug’s safety or efficacy results are questionable [5].
Post-approval studies seldom cover the "deficit of knowledge" (orphan drugs) [6]. FDA in their letters generally do not approve applications for new drugs for reasons related to safety and efficacy deficiencies [7]. Fast-track drugs approval by the FDA is harmful and not good for the public at large, the reason being that drug companies are paying huge sums to fast-track FDA approval [8].
Evidence based medicine appears to be broken owing to corruption in clinical research and also to overdiagnosis harming the patients & healthy people [9,10].
Big pharma companies seem to increase the costs of drugs owing to commercial & professional vested interests and health system incentives favouring more tests and treatments [11].
It is not just the responsibility of regulatory bodies at a high level: responsibility starts with "Investgators who are involved in the study" and “Institutional Ethics Committees” /or “Institutional Review Boards”, which have a major role in approving the projects/RCTs. Responsibility also lies with "Sponsors/ Funders" of the projects/RCTs.
The FDA should take appropriate measures to prevent the misuse of "Expedited regulatory pathways" for the safety of patients at large. Thank you for an interesting and a relevant research article.
Rapid Response:
RE: Expedited regulatory pathways and Misuse.
It is good to read the research article “Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study”.
Expedited approvals for new drugs include, “Accelerated approval pathway”, “Breakthrough therapy”, “Fast track designation”, and “Priority review”. The Food and Drug Administration (FDA) initiated “Accelerated approval regulations” in 1992, and the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 2012 allowed the FDA "Accelerated approval for the drugs for serious conditions" with an unmet medical need, based on a surrogate marker or an intermediate clinical endpoint; it also included “Breakthrough therapy”[1,2]. FDA designed a “Fast track process” to facilitate the development, & a “priority review” for faster review within six months (compared to 10 months under standard review) [3,4].
Drug companies must conduct a “confirmatory trial” once the drug is on the market in an accelerated approval program and the FDA must take appropriate action regarding its approval if the drug’s safety or efficacy results are questionable [5].
Post-approval studies seldom cover the "deficit of knowledge" (orphan drugs) [6]. FDA in their letters generally do not approve applications for new drugs for reasons related to safety and efficacy deficiencies [7]. Fast-track drugs approval by the FDA is harmful and not good for the public at large, the reason being that drug companies are paying huge sums to fast-track FDA approval [8].
Evidence based medicine appears to be broken owing to corruption in clinical research and also to overdiagnosis harming the patients & healthy people [9,10].
Big pharma companies seem to increase the costs of drugs owing to commercial & professional vested interests and health system incentives favouring more tests and treatments [11].
It is not just the responsibility of regulatory bodies at a high level: responsibility starts with "Investgators who are involved in the study" and “Institutional Ethics Committees” /or “Institutional Review Boards”, which have a major role in approving the projects/RCTs. Responsibility also lies with "Sponsors/ Funders" of the projects/RCTs.
The FDA should take appropriate measures to prevent the misuse of "Expedited regulatory pathways" for the safety of patients at large. Thank you for an interesting and a relevant research article.
Regards,
References:
1. https://www.fda.gov/ForPatients/Approvals/Fast/ucm405447.htm
2. https://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm
3. https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
4. https://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm
5. BMJ 2015;351:h5260
6. http://www.bmj.com/content/353/bmj.i2978
7. http://www.bmj.com/content/350/bmj.h2758
8. http://fortune.com/2015/10/20/pharma-fda-vouchers-resale/
9. http://www.bmj.com/content/348/bmj.g22
10. http://www.bmj.com/content/344/bmj.e3502
11. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4046551/
Competing interests: No competing interests