Generic vs Name Brand Drugs Scientistmel.com Twitter.com/scientistmel Patreon.com/scientistmel 4/13/2019 10 am

Drugs What are they? Compare/Contrast? How does it all work? What about cost?

Generic vs Brand Breakdown Same active ingredients, efficacy, entry (oral, IV) Same mode of molecular interaction Vary in inactive ingredients, packaging, and cost Drug development/Research is main difference

NP 1. First thing we have to do to explain the difference between the two is how a drug comes to market. The fda is a great resource on the differences between the two and how drugs come to market.  Space.com is a great resource to find an easy breakdown of the current working theories for the multiverse.

Discovery/Development Brand Drugs Discovery/Development Preclinical Research Clinical Research FDA Review FDA Monitoring There are 5 working theories regarding a multiverse.

Drugs

NP It can cost as much as $802 million over a period of 10-15 years to get a drug to market. Once the drug is approved, a patent is given to the company to allow it to recoup costs as well as make a profit. A patent lasts for 20 years. There are patents and there is exclusivity. FDA website states the difference: Patents and exclusivity work in a similar fashion but are distinct from one another and governed by different statutes. Patents are a property right granted by the United States Patent and Trademark Office anytime during the development of a drug and can encompass a wide range of claims.  Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements.  A new drug application (NDA) or abbreviated new drug application (ANDA) holder is eligible for exclusivity if statutory requirements are met.  See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, and 505(j)(5)(B)(iv) of the FD&C Act.  Periods of exclusivity and patent terms may or may not run concurrently. Exclusivity was designed to promote a balance between new drug innovation and greater public access to drugs that result from generic drug competition  

NP Orphan Drug Exclusivity (ODE) – 7 years New Chemical Entity Exclusivity (NCE) – 5 years Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities New Clinical Investigation Exclusivity – 3 years Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only) Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only  

Generic Drugs Pharmaceutically equal Correct manufacture Consistent manufacture Same active ingredients Same amount of active ingredients Inactive ingredients are safe Drug does not break down over time Appropriate packaging Same label Relevant patents/exclusivities expired Let’s like at this info graphic from the FDA on drug approval.

NP What if the generic med acts differently in me than the name brand? Some studies in past research have shown that there can be approximately 4% difference between brand name drugs and generic…according to Dr. Choudhry at Harvard University. The FDA allows as much as 20% variance, but only about 4% is seen in the market. It is important to note that the FDA does not require human testing for generic drugs. They require proof that it is the same drug…not the same effects. However, given that the compound in itself has already undergone extensive testing, the added testing for generic medications is not considered necessary as any added health risk would not be likely at all. The idea is to get life saving medications on the market at a lower cost for those who can not afford name brands recouping the extensive cost of research.  

NP Nearly 8 out of 10 prescriptions in the US are filled as generic. Generic tend to be 80-85% less than name brands. Let’s take a look at a graphic from blue cross blue shield on the cost of generic vs name brand drugs…  

NP While there may be some differences between generic and name brand drugs, the differences don’t really outweigh the benefit of choosing generic over name brand….especially given the cost and the US does not have a national health care system. Generic meds can still be expensive to the point of financially crippling. It’s time to take a look at the current system as research is expensive yet necessary to limit human suffering. Perhaps we really do need an overhaul on healthcare ti ensure people have access to medications that increase quality of life.  

SOURCES https://www.scientificamerican.com/article/whats-the-difference-betw-2004-12-13/ https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/genericdrugs /ucm167991.htm https://www.fda.gov/drugs/developmentapprovalprocess/ucm079031.htm#howlongpatentterm https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/genericdrugs /ucm506040.htm https://www.health.harvard.edu/staying-healthy/do-generic-drugs-compromise-on-quality https://www.bcbsm.com/content/dam/public/Consumer/Documents/about-us/brand-name-vs- generic-drug-costs.pdf https://www.health.harvard.edu/drugs-and-medications/the-cost-of-generic-and-name-brand- drugs

Drugs What are they? Compare/Contrast? How does it all work? What about cost?

Generic vs Brand Breakdown Same active ingredients, efficacy, entry (oral, IV) Same mode of molecular interaction Vary in inactive ingredients, packaging, and cost Drug development/Research is main difference

You can find me… ScientistMel.com Patreon.com/scientistmel Pscp.tv.com/scientistmel Youtube.com/scientistmel Facebook.com/scientistmel New patrons…Mark Sykes, Derp State, Rhetoric and Discourse

NP New patrons…Mark Sykes, Derp State, Rhetoric and Discourse Talk about goals…and hopes for more patrons.  

Generic vs Name Brand Drugs Scientistmel.com Twitter.com/scientistmel Patreon.com/scientistmel 4/13/2019 10 am