FDA rejects anti-addiction rule that would ban crushable Ritalin, opiates
- The FDA has rejected a proposal that would force drug makers to change the formulation of addictive drugs that play on the central nervous system -- such as Novartis' ADHD blockbuster Ritalin and opioid painkillers -- in order to make them harder to crush up and abuse, in-Pharmatechnologist.com reports.
- The proposal was presented in a petition from Dr. John Kulli, who has also filed a patent application for his own method of deterring the snorting of prescription medications.
- The FDA says that such a rule would be far too broad, and that there are too many unknowns regarding the effects that deterrent methods may have on patients.
According to in-Pharmatechnologist.com, the FDA responded to Dr. Kulli's letter by saying, "[T]he science of abuse deterrence is relatively new. Both the drug and formulation technologies involved, as well as the clinical, epidemiological, and statistical methods for evaluating those technologies, are rapidly evolving."
Furthermore, the agency pointed out that "adding a chemical to the drug might make it unpleasant to insufflate," but "it might also have the unintended consequence of making the tablet unpalatable or causing allergic reactions in susceptible patients."
Pharmaceutical companies naturally applauded the FDA's decision, while emphasizing that they are willing to work with Congress and the regulatory agency to make drugs safer and more difficult to abuse -- provided the industry has enough time to research and develop new formulations for drugs.
- in-Pharmatechnologist.com FDA says no to anti-addiction rule on Ritalin, painkillers