In 2017, the FDA restricted the manufacturing of Schedule II Opiates by 25%. Obviously the FDA has a critical role in controlling the manufacturing quotas of Schedule I and II substances. When setting quotas, the institution did their due diligence in reviewing:
- Estimates of the legitimate medical need
- Estimates of retail consumption based on prescriptions dispensed
- Manufacturers’ data on actual production, sales, inventory, exports, product development needs, and manufacturing losses
- Data from DEA’s own internal system for tracking controlled substance transactions
- Past quota histories
Critics say that the FDA’s reduced quota may lead to drug shortages for pain management and decrease access to other areas of pain management like oncology, hospice, and methadone clinics (Balick, 2016). Ab Osterhaus, a Dutch Professor, agrees that prescribers who write orders for inappropriate opioid treatments contribute to the problem (Balick, 2016). However, he believes that the DEA’s guidelines are premature and won’t be taken under advisement by practitioners immediately as there is not ample time for prescribers to transition patients to other pain management therapies.