Industry Challenges Hydrocodone Combination Reclassification in Citizen Petition

By Delia A. Deschaine

Various members of industry recently joined together in filing a citizen petition with FDA.  Citizen Petition, Docket No. FDA-2013-P-1711 (hereinafter “Citizen Petition”). The Citizen Petition responds to a statement made by CDER Director, Janet Woodcock, M.D. in October 2013 that FDA intends to issue a scientific and medical evaluation and recommendation that DEA reschedule all hydrocodone combination products from their current placement in Schedule III to Schedule II.  The petitioners argue that reclassifying all combination hydrocodone products is inappropriate for myriad of public policy reasons.  Thus they request that FDA instead recommend DEA reclassify only hydrocodone combination products that contain hydrocodone bitartrate in a strength of 5 mg or higher.  Citizen Petition at 2.  While the petition is brief, it touches on several critical points that FDA and DEA will likely consider in determining whether to move forward with the rescheduling.

To name a few points, the petitioners assert that reclassifying all hydrocodone products will have “numerous unintended consequences, including depriving vulnerable patient populations of access to critically-needed pain medications.”  Id. at 2.  The petitioners estimate that nearly 100 million Americans suffer from chronic pain and, thus, require opioid treatment for long periods of time.  Id. at 3.  These patients will also be negatively impacted by the reclassification of all strengths of hydrocodone products,  as the drug will become more costly to acquire, and, therefore, less available.  See id.  Further, the petitioners state  that the “upscheduling of hydrocodone combination products would require patients to see their doctor for office visits with greater frequency simply to refill a prescription,” and “[a]s FDA could imagine, such a policy change would impose heavy burdens  . . . on patients, caregivers and the health care system . . .”  Id.   (Unlike substances in Schedule III of the Controlled Substances Act, prescribers are not permitted to write refill prescriptions for controlled substances listed in Schedule II.)

The Citizen Petition is not the first response to the proposal to reclassify hydrocodone combination products, and likely not the last.  FDA and DEA have battled for years over the appropriate placement of hydrocodone combination products.  See prior post, here. The issue most recently attracted public attention in April 2012, when Congress declined to legislatively reclassify hydrocodone combination products.  See prior post, here.  Instead, Congress ordered FDA to convene a working group to discuss the risks and benefits of reclassification, which it did in January 2013.  Although FDA signaled its intent to issue a recommendation that DEA move forward with the reclassification by the end of the year (a departure from the position it took a few years ago, as petitioners noted), no public statement has been made that FDA did so.  We note, however, that FDA is not required to publish its recommendation in the Federal Register and historically has not done so.  For that reason, the four-page Citizen Petition may flush out whether FDA has or intends to issue its recommendation soon. (Pursuant to 21 U.S.C. § 355(q), FDA must respond to a citizen petition within 150 days if the petition may delay the approval of a pending 505(b)(2) or Abbreviated New Drug Application. )

Nevertheless, as the petitioners recognize, a DEA reclassification would likely have broad-sweeping implications for all members in the pharmaceutical distribution the chain of distribution.  See prior post, here.  These costs include compliance with the physical security requirements imposed on registrants for Schedule II controlled substances (i.e., that they be physically stored in secure cabinets or vaults (depending on the amount).  See 21 C.F.R. §§ 1301.71(a), 1301.72.  Currently, many pharmacies store hydrocodone combination products in safes or spread out shelves with other prescription drugs, and wholesalers store those products in cages (as opposed to vaults for Schedule II substances), as permitted by DEA.  Id. § 1301.72.  If hydrocodone products are reclassified in Schedule II, many pharmacies and wholesalers will need to alter their storage and security controls due to the widespread use and thus supply of these medications.  See id. § 1301.71(c) (requiring registrants to “expand[] or extend[]” their physical security controls “when [they] become inadequate as a result of a controlled substance being transferred to a different schedule”).  This may include vault construction or alteration which is difficult and costly, given DEA’s precise regulatory specifications.  Id. § 1301.72.

Because Schedule II prescriptions may not be refilled, the reclassification of hydrocodone would also likely impose additional costs on practitioners who routinely prescribe combination hydrocodone to patients requiring long-term opioid treatment.  Those costs may include administrative expenditures (e.g., supplies and support staff) necessary to handle an increased frequency of in-office visits by their patients.  Payers, such as Medicare, Medicaid, and private insurance, bear some of the burden of subsidizing these costs.  See Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014, 78 Fed. Reg. 43,282 (July 19, 2013) (discussing how administrative expenditures factor into the Medicare physician fee-for-service rates).

On balance, the petitioners argue, reclassifying only certain higher strength products serves to “protect[] vulnerable patient populations which rely on such medication without sacrificing the ability of DEA to target enforcement of drug products likely to be abused (i.e., products in 5 mg strength and above).”  Citizen Petition at 3-4.

The hydrocodone rescheduling petition relates to the many initiatives that FDA has recently taken to address concerns regarding the widespread misuse and abuse of opioids.   See, e.g., prior post, here. (discussing FDA’s new labeling for all extended release opioid drugs and biologics).  Despite these efforts, FDA recently came under scrutiny by lawmakers and state attorneys general for its approval of a single-entity hydrocodone drug (making it the first available U.S. hydrocodone drug in Schedule II), without requiring the drug to possess “abuse-deterrent technology.”  See prior post, here.  FDA did so despite finding earlier that year that drug manufacturer, Purdue, had withdrawn Oxycontin for safety or efficacy reasons, in the wake of FDA’s approval of a tamper-resistant formula for that drug.  Id.  FDA reasoned that its policy is to consider whether abuse-deterrent technology is necessary to ensure adequate safety of a drug on a “product-by-product” basis.  Id.  In response, The Pharmacists Planning Service, Inc. (“PPSI”) filed a petition with FDA (Docket No. FDA-2013-P-1606) requesting that FDA add “drug-abuse deterrent technology to all hydrocodone schedule II products.”  The petition listed concerns regarding the abuse of opioids generally, and, specifically, hydrocodone.  Id.  Interestingly, PPSI stated that “[it] has encouraged the FDA reschedule this hydrocodone/apap to schedule II.”  Id. at 2.

For now, we wait with curiosity to see whether, and how, FDA considers the arguments made in these petitions in issuing its scheduling recommendation to DEA.


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