Pharmaceutical Industry & Consumers Pearson, 2015-16

FDA Drug Approval Process http://www.fda.gov/Drugs/DevelopmentApprovalProc ess/default.htm Center for Drug Evaluation & Research Company tests drug (lab & animal tests first), sends evidence to CDER for independent review health benefits must outweigh known risks before approval for sale

Patent Protection & Generics Drugs are frequently patented during development, meaning no one else can sell the drug. When patent expires, other manufacturers can apply to sell generic. Patents allow for high prices, justified by high initial costs/bureaucracy of FDA approval

“Innovation . . . has become stagnant.” (FDA, 2004) New Drug Applications (NDAs) – down since 2004, while R & D expenses up dramatically Most NDAs are for “me-too” drugs, not New Molecular Entities (NMEs) “Me-toos” are very similar to existing, cheaper drugs What’s the result? Higher costs to consumers for little to no additional benefit

Some examples Prilosec - Nexium Prozac – Sarafem Claritin – Claritinex What happens when we simply take this practice (and patent protection) too far... Potential high-risk pregnancy? Don’t want to pay $1,000s for medicine to stay pregnant (when it used to cost less than $100s??) This is just one example. http://healthland.time.com/2011/03/10/can-patients-get- around-the-exorbitant-new-cost-of-a-pregnancy-drug/

Another important issue – Alzheimer’s Should companies be able to stop making a safe and effective generic and switch people to a more expensive new drug that doesn’t work as well? Fortunately, a federal appeals court said NO! http://www.prnewswire.com/news-releases/actavis- confirms-appeals-court-ruling-requiring-continued- distribution-of-namenda-ir-300088026.html

Pharmaceutical promotion to docs – can they still do that? http://www.pewhealth.org/other-resource/persuading- the-prescribers-pharmaceutical-industry-marketing-and- its-influence-on-physicians-and-patients-85899439814 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2811 591/ What if “WE” (as in public health focused physicians and researchers) took over “detailing”? http://www.alosafoundation.org/independent-drug- information-service/

DTC Ads Only US and New Zealand allow this practice! Read an interesting and brief take on this controversial practice:http://www.who.int/bulletin/volumes/87/8/09-040809/en/ FDA oversees it Print/TV – must have “brief summary” in print, list of side effects on TV ads TV ads can include only “most important” risks, as long as info on how to get more information Product claim: name a drug, condition, discuss benefits & risks Reminder: drug’s name, but not uses Help-seeking: describe condition, but don’t recommend/suggest specific drugs

Effects of DTC Ads 1999 study (Bell, et al) found 1/3 asked about a drug after seeing an ad, 1/5 asked for a prescription; most people believed ads were reviewed by FDA prior to print/air DTC ad growth  12% of the increase in spending on prescription drugs, ~$2.6 bil in 2000 (Kaiser Family Foundation, 2003)

FDA oversight of DTC ads http://www.fda.gov/Drug s/ResourcesForYou/Cons umers/ucm143562.htm http://content.healthaffai rs.org/cgi/content/full/hl thaff.w3.120v1/DC1 What the FDA says about this practice (we have this law, must be ok...) Looking at spending and effects of DTC vs. promotion to docs