- No refusal for pre-existing conditions for children
- no lifetime limites on coverage
- no-cost preventative care
- no lifetime limites on coverage
- no-cost preventative care
Showing posts with label history. Show all posts
Showing posts with label history. Show all posts
- accelerate approval for cancer drug, breakthru therapy to be on top of the pile (fast-track procedures)
FDA authority over
- direct-to-consumer advertising (Ex: have to report side effects on drugs ad.)
- packaging (Ex: tobacco must say it causes canccer)
- active post-trial surveillance system (Ex: REMS programs)
- publicize trial operations (Ex: tacrolimus)
- direct-to-consumer advertising (Ex: have to report side effects on drugs ad.)
- packaging (Ex: tobacco must say it causes canccer)
- active post-trial surveillance system (Ex: REMS programs)
- publicize trial operations (Ex: tacrolimus)
FDA is banned from establish efficacy and safety standards for supplements. Supplements do not need FDA-approval
Why it works?
Many supplements are non-Western medicine. Regulating non-western meds with western ways is controversial! ? Just my thought! May not be true!
Why it works?
Many supplements are non-Western medicine. Regulating non-western meds with western ways is controversial! ? Just my thought! May not be true!
Marketing = sample
Drug sample:
According to the Prescription Drug Marketing Act of 1987, the term "drug sample" means a unit of a drug, which is not intended to be sold and is intended to promote the sale of the drug. According to this act, the manufacturer or distributor of a drug subject may distribute drug samples by mail or common carrier to practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or other health care entities. The recipient of the drug sample must execute a written receipt for the drug sample upon its delivery and the return of the receipt to the manufacturer or distributor. (1)
Why it works?
Free sample is supposed to free, pharmaceutical companies do NOT make a profit on it. If prescribers sell these free samples, pharmaceutical companies lose profit. NOT ok!
(1) http://www.glossary.pharma-mkting.com/drugsample.htm
Drug sample:
According to the Prescription Drug Marketing Act of 1987, the term "drug sample" means a unit of a drug, which is not intended to be sold and is intended to promote the sale of the drug. According to this act, the manufacturer or distributor of a drug subject may distribute drug samples by mail or common carrier to practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or other health care entities. The recipient of the drug sample must execute a written receipt for the drug sample upon its delivery and the return of the receipt to the manufacturer or distributor. (1)
Why it works?
Free sample is supposed to free, pharmaceutical companies do NOT make a profit on it. If prescribers sell these free samples, pharmaceutical companies lose profit. NOT ok!
(1) http://www.glossary.pharma-mkting.com/drugsample.htm
incentives for drugs to treat rare diseases
These are orphan because it's become orphan of healthcare. Nobody in healthcare was caring for it with inventing the right drugs.
These are orphan because it's become orphan of healthcare. Nobody in healthcare was caring for it with inventing the right drugs.
scheduled drug started! (abuse = schedule!)
- mislabeling
- adulteration (must be pure!)
This Food, Drug, and Cosmetic Act of 1938 arise due to:
- Elixir Sulfanilamide: sulfanilamide pills was used to treat strep infxn. Unknowingly, chemists create solvent to create exlixir to treat pediatrics. The solvent caused deaths in peds. (1)
- "Consumers continued to be guinea pigs for the many new chemicals that were being added to food and cosmetics" (2)
=> Food, Drug, Cosmetic act requires: SAFETY & PURITY (but NOT efficacy just yet!. Meaning as long as it's safe and pure, you can just sell it, think OTC supplements!)
References:
(1): http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm054826.htm
(2): https://www.nlm.nih.gov/exhibition/phs_history/foodanddrugs.html
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efficacy, side effects, clinical trials
- Must show safety & EFFICACY (efficacy requirement started here)
- Guidelines for reporting side effects requirement (Thalidomide)
- Guidelines for conducting clinical trials (Thalidomide)
Mnemonics: Kefauver-Harris requires Thalidomide to prove side effects (birth defects) with correct clinical trials besides just its EFFICACY!
