The Food and Drug Administration will force generic manufacturers of powerful pain pills to switch to a tamper-resistant composition if it finds evidence the composition curbs prescription drug abuse and addiction, Alan Rappeport of The Financial Times reports. Public-health advocates worry that if generic versions of opiate pills are not made tamper-resistant, the prescription drug abuse epidemic may worsen.
If the agency finds tamper-resistance significantly deter abuse, it has legal authority to require generic drug makers to switch their opiate formulas. Just as manufacturers of some pain pills began switching formulas to make the pills harder to crush, easily crushable, generic forms of OxyContin and Opana were released. Purdue Pharma and Endo Pharmaceuticals, which make Opana, have hoped to extend patent life of their drugs by pushing the FDA to prevent generic makers from using old versions of their drugs. Generic makers argue this will keep patients from buying cheaper drugs.
The FDA said it will take a “flexible” approach to determining the effectiveness of tamper-resistant drugs because abusers are constantly finding new ways to avoid deterrents. (Read more)