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Product life cycle management is the lifeblood of the U.S. pharmaceutical industry. Consider, for example, that by year end an estimated40 drugs — generating combined annual revenues of more than $16 billion — will either come off patent or lose existing market exclusivity in the United States. Sales revenues for some of these drugs exceed $8 million per day.Extending U.S. exclusivity by a few months, weeks or even days represents significant revenue by any standard. The Best Pharmaceuticals for Children Act (BPCA), signed into law by President Bush on Jan. 4, gives brand-name drug manufacturersanother opportunity to extend their market exclusivity by six months. The BPCA extends the pediatric exclusivity provision of theFood and Drug Administration Modernization Act of 1997 (FDAMA) until October2007, with some amendments. The pediatric exclusivity provision permits theFood and Drug Administration (FDA) to grant a drug manufacturer an additionalsix months of market exclusivity for a brand-name drug if the manufacturerconducts acceptable pediatric studies for the drug. This six-month period ofexclusivity is added to the end of either a drug’s existing patent term or anyother existing market exclusivity term for an approved drug containing the sameactive ingredient as that subjected to the pediatric study. During thisexclusivity period, the FDA cannot approve a generic version of the drug. The section of FDAMA permitting an additional six-monthperiod of market exclusivity is known as the pediatric exclusivity provision.Congress enacted this provision, recognizing that information about the effectsof drugs and biological products in children was lacking. The provision’s solepurpose is to entice drug manufacturers to conduct pediatric clinical studiesin order to generate useful information about drug effectiveness in children. SEVERAL AMENDMENTS The BPCA not only extended the pediatric exclusivity programuntil October 2007, it also added several amendments to the program. Mostnotably among these amendments, the BPCA provides that approvals of a genericdrug will not be delayed if its labeling omits the pediatric information listedon the label of the brand-name drug, even if such information is protected by apatent or other market exclusivity. Other significant amendments to the programinclude: Clarification of the interaction between generic marketexclusivity and the six-month pediatric exclusivity periods. UnderHatch-Waxman, the first generic manufacturer that files a complete abbreviatednew drug application (ANDA) challenging a brand-name manufacturer’s patent maybe awarded six months of generic exclusivity. The generic exclusivity periodbegins on the date the patent term expires or is held invalid or unenforceableby a U.S. court. Pediatric exclusivity also begins on the date the patent termexpires or is held invalid or unenforceable by a U.S. court. Under the BPCA,the generic exclusivity period will be restored by the same amount of time itoverlapped with the pediatric exclusivity period. Written requests for drugs that have market exclusivity. Awritten request is a specific document in which the FDA requests submission ofcertain studies to determine if the use of a drug could have meaningful healthbenefits in the pediatric population. If the new drug application (NDA) holderfor a drug does not agree to conduct the pediatric studies specified in thewritten request, the FDA may ask the Foundation for the National Institutes ofHealth to award a grant to conduct such studies, even though the drug hasremaining market exclusivity. Sunset provisions. A drug cannot receive a six-monthpediatric exclusivity period unless, on or before Oct. 1, 2007, the FDA issuesa written request for pediatric studies of the drug; the NDA for the drug isapproved; and all requirements of the pediatric exclusivity provisions are met.It is important that brand-name manufacturers planning to ask the FDA to issuea written request do so in time to permit the FDA to review the proposedpediatric studies and issue a written request before Oct. 1, 2007. One of the most significant benefits of pediatricexclusivity is that it attaches not only to the product studied in thepediatric population, but also to all the applicant’s formulations, dosageforms and indications for products with existing marketing exclusivity orpatent life that contain the same active ingredient. For example, assume a brand-name manufacturer obtainedapproval for an oral formulation, an intravenous formulation and a topicalcream containing the same active ingredient. Here, all the products haveremaining market exclusivity or patent life. If the brand-name manufacturerconducts studies regarding the active ingredient in the oral formulationpursuant to the FDA’s requirements, an additional six-month exclusivity periodwill be granted to all dosage forms and all indications with the same activeingredients as the drug studied. In addition, pediatric exclusivity will beadded after the expiration of any patent covering the active ingredient or anapproved use of such ingredient. Generally, products with no patent life or exclusivityremaining cannot qualify for pediatric exclusivity. Under certain conditions,however, pediatric exclusivity may be granted to a product without remainingexclusivity if the pediatric studies themselves qualify for a new exclusivityperiod under the Hatch-Waxman Act. For example, assume a drug approved for use in adults has nopatent life or exclusivity remaining. If that drug were subsequently approvedfor use in children pursuant to a written request, then the drug could earnthree years of market exclusivity under the Hatch-Waxman Act, plus anadditional six-month pediatric exclusivity period. However, such exclusivity has limited value because itapplies only to use of the drug in children, not adults. Thus, during thethree-and-a-half-year combined exclusivity period, the FDA can still approve ageneric drug for use in adults. However, while the generic drug’s label willcontain no pediatric information, doctors will nonetheless prescribe the generic”off label” to children during the pediatric exclusivity period andbeyond. This off-label use substantially weakens the value of the pediatricexclusivity. For this reason, manufacturers typically do not pursue pediatricexclusivity unless they can add it to the term of a patent or the end of afive-year exclusivity period, thus preventing the FDA from approving acompeting generic during the pediatric exclusivity period. A pediatric study need not be successful in order for thedrug to qualify for exclusivity, nor is pediatric exclusivity dependent onwhether information from the requested study is included in the drug’s label.Provided the brand-name manufacturer submits a study that meets the FDA’srequirements, six months of pediatric exclusivity will be awarded. In addition, pediatric exclusivity applies to thoseover-the-counter drugs that are the subject of an approved NDA. If an ANDA is ready for approval after submission of apediatric study report for the corresponding brand-name drug, but before theFDA has accepted the report, the FDA will delay approval of the generic for upto 90 days while it makes a decision. If exclusivity is then granted, the sixmonths are considered to have been running during that delay period. Further, under limited circumstances, a drug may receive twosix-month exclusivity periods. For instance, if one six-month exclusivityperiod has already been earned for a drug, an additional six months may beadded to a three-year exclusivity period granted for a new indication under theHatch-Waxman Act. The second six-month period, however, cannot delay approvalof an orphan drug application or an ANDA. PEDIATRIC EXCLUSIVITY Pediatric exclusivity can be earned for an already-approveddrug and also for a drug in the approval process. For an approved drug, threeessential elements must be satisfied before it is eligible for pediatricexclusivity: The applicant must receive a written request from the FDArequesting that pediatric studies be performed on the drug. The written requestdescribes the studies needed and the timeframe for their completion. The studies must be submitted within the timeframespecified in the written request. The studies performed must meet the terms specified in thewritten request. The procedures for drugs in the approval process areessentially the same for approved drugs, except that the nonapproved drugs neednot be on the FDA’s priority list. Also, such studies need not be completedbefore the NDA is approved for nonpediatric use. It is critical that companies be aware that they can ask theFDA to make a drug eligible for pediatric exclusivity. That is, even if thedrug is not on the FDA’s priority list, an applicant can submit a proposedpediatric study for its drug to the FDA and request that the FDA issue awritten request for the drug. The FDA strongly encourages manufacturers tosubmit proposed pediatric study requests for their drugs. As of Nov. 1, 2001,the FDA had received 281 such requests. Of those submissions, 208 were granted,each resulting in the issuance of a written request. The procedure forrequesting that the FDA make a drug eligible for pediatric exclusivity isprovided at www.fda.gov/cder/ guidance/2891fnl.htm. It is crucial that manufacturers plan to submit theirproposed pediatric study requests with sufficient time to permit the FDA toreview the proposed study request and issue a written request; the manufacturerto initiate, complete and file the pediatric study report; and the FDA toreview and approve the report before expiration of a U.S. patent or otherexclusivity period. Pediatric exclusivity is an add-on to existing marketingexclusivity or patent protection. If the patent or exclusivity period expiresbefore the pediatric data is submitted and accepted by the FDA, no exclusivitywill be awarded. Preferably, a drug company should submit its request atleast three years before expiration of a U.S. patent or exclusivity period. Ifa company is unfamiliar with FDA practice, it should consider hiring outsidecounsel familiar with FDA regulations. While this may seem costly at first,depending on the value of the brand-name drug, the value to the company inextending the drug’s life cycle for an additional six months can be great. Thomas J. Parker is of counsel, and Amy S. Manning is anassociate, in the intellectual property practice group at New York’s CoudertBrothers, www.coudert.com.

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