The FDA's lengthy warning letter of July to pain patch maker Haw Par Healthcare is more than just a list of GMP violations. It's a shot across the bow for pain patch makers everywhere.
Haw Par makes the Tiger Balm pain patch. The picture of the Singaporean company painted in the warning puts it in sharp contrast to Japanese competitor Hisamitsu, maker of the Salonpas patch. Haw Par was cited for everything from a lack of QC underpinning, inadequate discrepancy investigations, and misbranding to failure to monitor suppliers and to follow production and process control procedures.
Hisamitsu, by contrast--currently the only OTC patch maker that has earned pre-market approval for its product--has met the FDA on friendlier terms, undergoing the plant audits and review of safety and efficacy data familiar to traditional drugmakers.
In so doing, Hisamitsu stands apart from not just Haw Par, but also OTC pain patch makers Johnson & Johnson (Ben Gay), Chattem/Sanofi (Icy Hot), and others, notes Donald Riker, president at On Point Advisors. "What's interesting is the disastrous Tiger Balm plant audit and what that means to J&J and Chattem/Sanofi, who also depend on Asian third-party manufacturers," says Riker via email. All topical pain patch manufacturing is done in Asia, he adds.
The pain patch business is in a kind of regulatory limbo, says Riker. The FDA has issued no final ruling on its regulation, despite a petition by the Consumer Healthcare Products Association. CHPA asked the FDA in April to arrive at a regulatory conclusion that might sidestep pre-marketing NDAs in favor of a monograph amendment. But the regulator will likely close the External Analgesic Monograph in December sans topical pain patch amendment, says Riker.
If the FDA ultimately requires NDAs, "Hisamitsu has a big head start," Riker says. The foreign manufacturer has "played by the rules" while domestic manufacturers appear to have "placed their bets on the usual slowness of the FDA and are still playing the clock."