The 700-plus products are now available without a prescription because the FDA, in cooperation with panels of outside experts, determined they could be used safely and effectively without a doctor's supervision.
The FDA has given OTC approval to drugs with such household names as Children's Advil and Children's Motrin (ibuprofen), Orudis KT and Actron (ketoprofen), and Aleve (naproxen sodium) for pain relief and fever reduction; Femstat 3 (butoconazole nitrate) for vaginal yeast infection; Pepcid AC (famotidine), Tagamet HB (cimetidine), Zantac 75 (ranitidine hydrochloride), Axid AR (nizatidine), and Prilosec OTC (omeprazole magnesium) for heartburn; Rogaine (minoxidil) for hair growth; and Claritin (loratadine), the first non-sedating antihistamine.
The FDA believes that there is an important trend toward consumer participation in their own health care. It's part of the agency's mission to keep up with the consumers' wish to be more involved.
Switches have a huge impact on the health care economy. The greater availability of medicines over the counter saves approximately $20 billion each year, according to a 1997 study by the CHPA. The $20 billion takes into account prescription costs, doctor visits, lost time from work, insurance costs, and travel.
When considering an Rx-to-OTC switch, the key question for the FDA is whether patients alone can achieve the desired medical result without endangering their safety.
No drug is absolutely safe. There are risks associated with every medication, so the FDA does a benefit-to-risk comparison to determine whether it is appropriate for consumers to self-medicate with a drug for a certain use.
On the safety side, the agency looks at the drug's toxicity--its potential for poisonous effects--when the drug is used according to its labeled directions, and also from foreseeable misuse of the drug.
The FDA weighs a drug's safety against its benefit to patients. The agency considers whether consumers will be able to understand and follow label directions, whether patients can diagnose the condition themselves--or at least recognize the symptoms they want to treat--and whether routine medical examinations or laboratory tests are required for continued safe use of a drug.