Petition Seeks FDA’s “Forced Switch” of ALLEGRA and ZYRTEC to OTC Status

March 20, 2007

On March 12, 2007, Greenberg Traurig submitted a citizen petition to FDA to switch four prescription antihistamine and antihistamine-decongestant drugs from prescription to OTC status.  The four drugs are ALLEGRA (fexofenidine HCl), ALLEGRA D (fexofenidine HCl; pseudoephedrine HCl), ZYRTEC (cetirizine HCl), and ZYRTEC D (cetirizine HCl; pseudoephedrine HCl).  The petition cites several bases justifying the forced switches –all of which are related to FDA’s previous discussion and actions concerning the OTC status of CLARITIN (loratadine). 

Interest in the issue of forced Rx-to-OTC switches has waxed and waned over the past several years.  In July 1998, Wellpoint Health Networks submitted a petition requesting that FDA switch CLARITIN and the other drugs mentioned in the Greenburg petition to OTC status.  In May 2001, FDA held a joint meeting of the Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committees to consider the issue.  Although the committees recommended the Rx-to-OTC switches of ALLEGRA, ZYRTEC, and CLARITIN, FDA took no formal action on the recommendation.  FDA has not yet responded to the Wellpoint petition, and may never do so.  Wellpoint has reportedly lost interest in pursuing the issue because the company’s petition stimulated enough discussion to assure the company that FDA and the pharmaceutical industry are actively considering Rx-to-OTC switches.  Indeed, in November 2002, FDA approved the Rx-to-OTC switch of several CLARITIN drug products. 

FDA attempted to force an Rx-to-OTC switch over the objections of the product’s sponsor once –in 1982, FDA proposed the Rx-to-OTC switch of metaproterenol sulfate metered-dose inhalers– but did not carry through with the switch after extensive adverse comment.  Since the switch of CLARITIN, FDA has indicated its preference to “stimulate” switches rather than force them.  The Greenberg petition, however, places the issue front and center once again.  With respect to FDA’s legal authority to force Rx-to-OTC switches, the Greenberg petition includes an 8-page legal memorandum analyzing the issue.  Three primary legal arguments are made: 

First, the [FDC Act] expressly authorizes [FDA] to switch a drug from prescription to OTC following rulemaking.  There is no statutory provision that even suggests, let alone requires, that rulemaking in this setting must give way to adjudication, i.e., formal trial-like proceeding.

Second, unless there is a statutory provision to the contrary, the courts have consistently held that an agency is free to undertake any type of rulemaking it deems appropriate.  Here, there is nothing that would interfere with that agency prerogative.

Third, there is nothing in the [FDA Act], [FOIA], or any other federal law that would preclude the agency from making regulatory decisions about a drug based on drug-specific data submitted to it by the drug’s sponsor.  While the [FDC Act] and FOIA may limit public disclosure of these data, they in no way affect the ability of the FDA to use the data as part of a rulemaking.  One cannot equate “use” of data by the agency with public disclosure.  In short, a decision concerning whether to switch a product from prescription to OTC is committed to agency discretion and should be based on the scientific merit of the petition and not hindered by artificial legal constraints that nowhere appear in federal law.

Categories: Drug Development