As of April 16 the US Drug Enforcement Agency (DEA) will increase annual fees for manufacturers of controlled substances to $3,047 (€2,336), a jump of more than 30 per cent. The increase is the first since 2006 and will cover rising costs and expansion of the diversion control program (DCP).
“Congress has expanded the scope of the DCP through budgetary and legislative action in order to address an increase in the diversion of controlled substances and listed chemicals that seriously impact public health and safety”, the DEA wrote in its justification of the fee increase.
When the DEA proposed the increase in July it was swamped with comments from nurses and other healthcare professionals that must also pay the fees. In contrast, manufacturers were quiet on the proposal.
Under the approach taken by the DEA manufacturers pay far more than those dispensing controlled substances. The DEA still faced a backlash from healthcare professionals and hospitals though who criticised the timing of the increase and called on the Agency to delay it until the economy improves.
700% = Unreasonable
An option considered by the DEA was increasing the burden on manufacturers to lessen payments for others. Analysis of the ‘Future-Based Option’, in which fees are calculated by looking at projected work hours, showed it would have increased manufacturers’ payments by more than 700 per cent.
The DEA decided this was “unreasonable” and instead stuck with the weighted model it has used in the past. Under this model manufacturers must pay 12.5 times the base fee – twice the charge for distributors.