1. Pharmaceutical Industry & Consumers
Pearson,

2. FDA Drug Approval Process
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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

4. 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

5. “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

6. 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.
around-the-exorbitant-new-cost-of-a-pregnancy-drug/

7. 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!
confirms-appeals-court-ruling-requiring-continued- distribution-of-namenda-ir html

8. Pharmaceutical promotion to docs – can they still do that?
the-prescribers-pharmaceutical-industry-marketing-and- its-influence-on-physicians-and-patients
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What if “WE” (as in public health focused physicians and researchers) took over “detailing”? information-service/

9. DTC Ads
Only US and New Zealand allow this practice! Read an interesting and brief take on this controversial practice:
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

10. 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)

11. FDA oversight of DTC ads
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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