Proposed FDA hydrocodone rules could dampen sales, warns Fitch

Tougher regulations proposed this month by the US Food and Drug Administration regarding combination drugs that contain hydrocodone as an active ingredient (The Pharma Letter October 25) could dampen sales as prescribing restrictions increase, according to Fitch Ratings.

The new rules, which are expected to become effective early next year, will not have an impact on Fitch's rated US branded drug manufacturers as none are particularly exposed to hydrocodone.

However, raising the Drug Enforcement Administration (DEA) control level could slow sales as the new regulations would reclassify products containing hydrocodone to Schedule II from Schedule III drugs. That would place the painkiller, which can cause addiction, among other medications with a high potential for abuse (ie, morphine, fentanyl, meperidine, methylphenidate).