October 28th Pages 957-985 United States v. Article of Drug... "Decholin" (Page 958) o Is Decholin unsafe as a drug intended for human use without a prescription? Congress did not desire to proscribe self medication with a product just because under some set of circumstances- and especially hypothetical conditions - the drug may be harmful if taken without supervision... Switch from prescription to OTC o Most common one now is by supplement and new drug application for drug that is already approved Unlikely that newly introduced OTC got OTC other than by supplemental NDA (true for the last 10 years or so) Switch regulation Some push back on making aspirin OTC Why would they oppose a Rx switch to OTC in the 1950s? At that time- promote drugs directly to doctors Worried about offending the doctors Social policy o FDA does not address social policy . Not in the Act Tummino v. Hamburg - Plan B case o Used to be only available for those over 18 and you needed a prescription Two different channels trying to make switch to OTC Citizen petition By the manufacture Unusual exercise by authority- Secretary of state Directed FDA not to approve it She said it was unsafe Not really unsafe- she just was using it politically because didn't want it in the hands of children because nature of drug Public policy If she would have said if FDA says it is safe, I believe them but as a matter of public policy that she did not believe it should be approved Judge would have then had to answer the question of whether the FDA should consider social policies when approving drugs o Once have a age restriction on drug- Has to be sold in a pharmacy at the hours the pharmacy is open since it is kept behind the pharmacy counter and they have to check your ID Outcome FDA does not want to grant the citizen petition Doesn't want it to be seen that they approved the switch because of the petition So they propose to judge (which the judge goes with) that the company file a NDA for new indication and they would approve it right away When a new drug comes into the market they have 3 year exclusivity o Therefore if a drug is for two different things and one thing is allergies, the generic can not market that they are for allergies.
Even though the pharmacies will still fill the generic, so it doesn't really matter 0 This is not the case with the switch from Rx to OTC Combination OTC Drugs o Fixed dose combination - when have a drug with a combination FDA hates them - drug companies love them Sometimes have combinations that don't make sense or combination that causes over medication Pages 996-1006 Generic Drugs
Let them get approved by papers (information in paper and not supported by actual research) FDA and Generic Drugs before Hatch-Waxman Hoffman-LeRoche, Inc. Weinberger (Page 997) Challeng