As part of FDA’s continuing efforts to complete its Drug Efficacy Study Implementation (DESI) review, FDA published a July 24, 2012, Federal Register notice offering companies an opportunity to affirm hearings related to certain DESI dockets. The companies have 30 days to respond to FDA or else FDA will deem the hearing requests to be withdrawn.
The affected DESI dockets include:
- Certain drug products containing an anticholinergic in combination with a barbiturate,
- Combination drug containing a xanthine derivative,
- Certain single entity antispasmatic drug ,
- Certain drug products containing anticholinergics/antispasmodics in combination with a sedative, and single-entity antispasmodics,
- Certain chlorthalidone drug products,
- Certain drug products containing chlortetracycline and tetracycline,
- Certain combination drug products containing hydrocortisone acetate and pramoxine hydrochloride
In the earlier DESI dockets applicable to these products, FDA deemed the affected products to be “less than effective” and, under the DESI procedures, the sponsor of the product was able to request a hearing on FDA’s finding. By requesting hearings, these companies were able to prolong the DESI process and continue to market the product subject to FDA’s longstanding policy that permits a product subject to an ongoing DESI proceeding to remain on the market during the pendency of the proceeding. (FDA rarely held hearings in response to such requests.) Moreover, other similar products could be marketed during the pendency of these proceedings on the theory that they are “identical, related, or similar,” to these products.
Once these DESI proceeding are concluded, however, FDA will have definitively concluded that these products – and those that are on the market as “identical, related, or similar” to them – are unapproved new drugs. Such a finding would not only make the continued marketing of these products illegal, but would also mean that such a product would likely no longer qualify as a “covered outpatient drug” under section 1927(k)(4) of the Social Security Act that governs the Medicaid Drug Rebate Program. Continuing to seek reimbursement for a drug that is not a “covered outpatient drug” may lead to liabilities under the Federal False Claims Act.
Notably, this is not the first time FDA has used such a tactic to conclude pending DESI proceedings. In February of 2011, FDA issued a similar request for companies to affirm DESI hearing requests for a different set of drug products. As a result, the following month, FDA issued a follow-up notice withdrawing numerous hearing requests for particular products, thus concluding the applicable DESI proceedings and categorizing the products (and those that are “identical, related, or similar,” to them) as unapproved new drugs.