FDA Announces “Proactive” Approach To Rx-To-OTC Switches

FDA plans to take a more active role in initiating Rx-to OTC switches in coming years, Senior Associate Commissioner for Management & Systems Jeff Weber said Feb. 3.

Speaking at a press conference on the agency's proposed budget for fiscal year 2004, Weber noted FDA expects to "look at some products for Rx-to-OTC switches and proactively try to get those switches done, rather than wait for applications for switches to come in from industry voluntarily."

The plan is part of a broader agency initiative to "provide consumers with faster access to OTC drugs without compromising the safety of those drugs," Weber said.

Although FDA would not elaborate as to which drug classes or products it is looking at, second-generation antihistamines would appear to be prime candidates for agency attention.

The idea of FDA-initiated switches first came to the forefront after WellPoint Health Networks petitioned the agency in 1998 to switch Schering-Plough's Claritin , Aventis' Allegra and Pfizer's Zyrtec (¹ (Also see "OTC Sale Of Rx Allergy Drugs Would Be Safer, Cut Costs - Health Plan" - Pink Sheet, 25 Jan, 1999.), p. 20).

Weber's announcement appears to be consistent with budget language noting FDA has set a goal "to increase Rx-to-OTC switches by 50% on average." While the figure is a benchmark, the agency adds it "cannot control this on a year-to-year basis and has not made [the goal] an annual performance measure."

FDA's FY 2004 budget proposal seeks a $1 mil. increase in funding for OTC-related activities. The increase would raise the agency's OTC budget about 10.6% to nearly $10.4 mil.

The extra funds would help "support the hiring and training of seven [full-time equivalents] to: improve the OTC regulatory process so that FDA is better equipped to provide the consumer faster access to OTC drug products without compromising safety issues; expedite the review of Rx-to-OTC switches; and develop and work toward finalizing standards" for several OTC monographs, FDA's budget says.

The seven additional FTEs would bring the number of nonprescription drug-dedicated staff up to 69.

In addition to becoming more involved in the switch process, FDA's OTC objectives include increasing its "consideration and identification of drugs with only foreign marketing experience as candidates for the U.S. OTC market," the FY 2004 budget says.

The agency published its final rule outlining the requirements for OTC approval of foreign-marketed drugs in early 2002 (² (Also see "OTC “Time & Extent” Requirements Reduced For Extensively Marketed Drugs" - Pink Sheet, 28 Jan, 2002.), p. 3). The rule addresses what information should be included in "time and extent applications" and what constitutes foreign marketing for a "material time" and to a "material extent."

Regarding the OTC drug review, FDA's budget notes the agency expects to complete approximately six monographs in FY 2004, including those for internal and external analgesics, healthcare antiseptics, sunscreens and laxative drug products.

The last major OTC initiative increased funding will support is "FDA's effort to become a leader in developing research to better understand consumer behavior," the budget proposal says.

"Many manufacturers are not willing to expend the resources needed to identify possible solutions to errors in consumer use and selection," the budget states, adding research is needed to "identify mechanisms for influencing appropriate consumer use of products."

The agency notes its efforts to increase OTC availability are "especially relevant given the rising costs of [Rx] drugs." In line with this concern, FDA also is seeking extra funding for the Office of Generic Drugs.

FDA is requesting an additional $13 mil. for OGD, $12.4 mil. for the center and $600,000 for field activities (³ (Also see "FDA Generics Review Staff To Increase 25% In President’s Budget Request" - Pink Sheet, 27 Jan, 2003.), p. 13). The 28.8% jump would bring generics spending to $58.1 mil. and cover the hiring of 35 center FTEs to speed the ANDA review process and five field FTEs to support increased facility inspections.

The agency's goal is to "complete review and action on 90% or better of original applications within 180 days and decrease the median time to full approval from 18 months to 16-17 months."

Other increases being sought by FDA include an extra $5 mil. "to expand availability of drugs for children in accordance with the Best Pharmaceuticals for Children Act (BPCA)."

The budget proposal notes the monies would support the hiring of 4 FTEs in the Office of Pediatric Therapeutics "to address all activities related to the increasing number of new pediatric studies submitted by the pharmaceutical sponsors."

CDER's planned consolidation into the White Oak, Md. and College Park, Md. campuses is mentioned as well, with FDA requesting $6 mil., "primarily for cabling and relocation support contract services."

In a Feb. 4 letter to HHS Secretary Tommy Thompson, several members of Maryland's congressional delegation call the current FY 2003 funding levels for the FDA move "woefully inadequate" and urge Thompson "to intercede with...the White House to ensure that...a long-range funding commitment is made to complete the remaining phases...of the consolidation and modernization project by 2008," which are estimated at $614 mil.

Overall, the agency's human drugs program would grow roughly 9.6% above estimated 2003 levels to $303.8 mil., with $220.2 mil. going to the Center for Drug Evaluation & Research and $83.6 mil. going to its field offices.

Including fees collected under the Prescription Drug User Fee Act, FDA's human drugs program would receive nearly $485.9 mil., a 14% increase over estimated FY 2003 budget levels. The human drug program's total FTEs would rise 10.4% to 2,274; including those funded by user fees, the program's FTEs would number 3,247.

Spending for the Center for Food Safety & Applied Nutrition would decrease 2.5% to $144.4 mil., but the decline would be offset by increased funding for field activities, which would grow 1.8% to $268.9 mil. "Reductions have not been made to specific programs pending FY 2003 Appropriations," the budget notes.

The vast majority of new funds for the agency's foods program would go toward "food safety activities related to counterterrorism." The FY 2004 budget proposal requests a $20.5 mil. increase for the activities, with $10.5 mil. earmarked for the continued development and maintenance of food registration and prior notice databases mandated under the Public Health Security & Bioterrorism Preparedness and Response Act of 2001.

FDA issued separate proposed rules concerning the registration of food facilities and prior notice of imported food shipments, both of which apply to dietary supplement and infant formula firms, in the Feb. 3 Federal Register (⁴ (Also see "Electronic Facility Registration Encouraged In FDA Bioterrorism Reg" - Pink Sheet, 3 Feb, 2003.), p. 3). The agency expects to publish final rules on both topics in October.

Another $5 mil. would go toward funding "state contracts, grants and partnerships related to FDA regulated products to inspect and monitor the food industry frequently." The final $5 mil. would fund laboratory work to "support public health preparedness," the budget says.

"By the end of FY 2003, FDA estimates an increase of 100% over FY 2002 food field examinations," the proposal notes. In total, spending on food safety counterterrorism activities would reach $116.3 mil. in FY 2004, FDA believes.

With bioterrorism initiatives CFSAN's top priority, the amount of attention dedicated to dietary supplements appears to be diminished. CFSAN said the FY 2004 budget request does not include any specific increases for dietary supplement-specific activities.

The lack of funding increases could significantly hamper the agency's ability to review supplement health claim petitions. In a Jan. 15 letter, CFSAN Director Joseph Levitt indicated the center's newly implemented, less stringent health claim approval standards likely will lead to an influx of petitions (⁵ (Also see "Prioritized, Consolidated Health Claims Petitions Requested By FDA’s Levitt" - Pink Sheet, 20 Jan, 2003.), p. 3).

In total, FDA's FY '04 budget request comes to almost $1.41 bil., up about 1.6% from the FY 2003 proposed funding level. With user fees, the agency would receive $1.71 bil., a 3.5% increase.

While many of the various line items in the FDA '04 budget request appear to represent significant funding increases, determining actual increases is difficult because growth estimates are based on the Administration's FY 2003 budget proposal.

However, the '03 spending bill still has not passed out of Congress; if the final version differs from the Administration's proposal, as it likely will, the comparisons to the FY 2004 numbers will change as well.