In a response to a letter from a US doctor John Kulli, the FDA refused to impose a general requirement to reformulate all CNS-stimulant drugs so they cannot be crushed into powder for snorting or injecting.
The agency said while it supports efforts to prevent drug misuse, “the 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.”
There are too many unknowns among current anti-abuse technologies, the FDA wrote. “For example, although adding a chemical to the drug product might make it unpleasant to insufflate, it might also have the unintended consequence of making the tablet unpalatable or causing allergic reactions in susceptible patients.”
It also noted that transdermal patches, which are harder to tamper with for snorting or injection than pills, “are not an appropriate therapeutic choice in many instances.”
‘Congress, not FDA’
CLAAD (Center for Lawful Access and Abuse Deterrence), a coalition which includes pharma companies Purdue and Allergan, told in-Pharmatechnologist.com it supports making anti-abuse formulation compulsory, but not by a named date.
The FDA must give “adequate time for the manufacturers to develop the technologies to allow adequate competition in the market, and adequate incentives to make the transition scientifically and medically sound,” Kyle Simon, Director of Policy and Advocacy, told us.
“We want to make sure that any mandatory transition, whether legislative or regulatory, allows [time for] R&D.” Manufacturers should be given a period to develop their own anti-tampering tech or to find a licensing partner, he said.
Simon said CLAAD expects anti-abuse formulation rules to pass eventually – “likely as a legislative mandate rather than regulatory – via Congress, not FDA.” Legislation on the matter is proposed for the next Congress in February 2015.
John Kulli, the doctor behind the rejected petition, also filed a patent application in 2012 for the type of technology he advocates in the petition, a method of deterring substance abuse whereby “the drug is formulated into a form (not a transdermal patch) that tends to deter conversion to powder.”
Aside from preventing pill-crushing, other abuse-deterrent techniques are available: some use opioid antagonists which will neutralise the effect of the prescribed drug if a pill is tampered with. Intellipharmaceutics told in-Pharmatechnologist.com earlier this month it has patented a formulation that blocks API uptake in case of oral overdose.