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BPCA and PREA work together as an effective two-pronged approach to generate pediatric studies. PREA provides FDA the authority to require pediatric studies of drugs when their use for children would be the same as in adults. BPCA provides a voluntary incentive to drug manufacturers of an additional six months of marketing exclusivity for conducting pediatric studies of drugs that the FDA determines may be useful to children. Since the passage of FDAMA over a decade ago, FDA has requested nearly 800 studies involving more than 45, 000 children in clinical trials through a written request. The information gained from these studies resulted in label changes for 128 drugs.1 By comparison, in the seven years prior to FDAMA, only 11 studies of marketed drugs were completed, though 70 studies were promised. While similar data tracking PREA's effectiveness is not been publicly available, FDA's website credits 55 label changes to PREA. AAP hopes this year's reauthorization will improve tracking and reporting of PREA's results. As a clinician, I cannot overstate the importance of what we have learned through the pediatric studies generated by these laws. Children's differing metabolism, growth and development, and size have very large effects. The performance of medications in children's bodies is even more dynamic and variable than we anticipated. Indeed, we have really learned, once again, that children are not just small adults. And the more we learn, the more we realize what we didn't know. For example, pediatric studies and resultant labeling have: given pediatricians the ability to give the correct dose of pain relief medicine to children with chronic pain that were previously under dosed Neurontin warned ICU physicians that a drug used for sedation in ICUs had twice the mortality rate as another drug combination Propofol given pediatricians and child psychiatrists important information on both the relative effectiveness and serious side effects of anti-depressant medication in adolescents Prozac, Paxil, et al. given children increased relief of pain from medicines taken by mouth, breathed into the lungs, given through the vein, and absorbed through the skin; and, alerted both pediatricians and parents about unexpected side effects of medications that have allowed for a more complete discussion of both the risks and benefits of a particular therapeutic course.

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Table 1. DSM-IV criteria for premenstrual dysphoric disorder. Major Depression or Dysthymic Disorder may be present. The selective serotonin re-uptake inhibitors Prozac, Celexa, Zoloft. Paxil, Luvox ; may be helpful, though the data from controlled studies are mixed. Patients with evidence of Obsessive-Compulsive symptoms may also respond positively to the SSRIs and penicillin. Susannah Mayhew et al. pseudo-patients claimed to have no money with them and left without purchasing any drugs. This did create some difficulties since some pharmacists were reluctant to give advice or dosage details without first seeing the money. Specific therapeutic recommendations were therefore only obtained for 5059% of pharmacists in the pre- and post-training pseudo-patient surveys. Where drug names and prices were obtained, they were recorded by the pseudo-patients on departure from the pharmacy. 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Hydrochloride ; until expiration of TorPharm's exclusivity.39 The Department of Justice appealed for FDA, 40 but the contested exclusivity period expired on March 6, 2004, and on December 17, 2004, the D.C. Circuit dismissed the appeal as moot.41 Although this district court's decision on paroxetine would appear to have settled the issue, another judge on the same court took the opposite view. This case, also, involved TorPharm--now known as Apotex--but a different drug, Neurontin gabapentin ; . Purepac submitted an ANDA in March 1998 and was the first to submit a paragraph IV certification for a patent. Apotex submitted an ANDA in April 1998, including a paragraph IV certification to the same patent. While patent infringement litigation on that patent was pending against both applicants, Warner-Lambert listed another patent. Purepac and Apotex amended their ANDAs. Apotex prevailed in its litigation on the first patent, and Warner-Lambert did not appeal. This triggered Purepac's exclusivity on the first patent, which ran from October 2001 to April 2002. FDA then took the position that Purepac was entitled to exclusivity on the second patent as the first filer on that patent ; and that final approval of Apotex's ANDA was subject to the second exclusivity term. Apotex brought suit, taking issue with FDA's conclusion that Purepac had been the first filer on the second patent and that Apotex would have to await a relevant court decision on that patent or commercial marketing by Purepac. It also argued that the paroxetine decision means there can be only one exclusivity period per innovator product and that the exclusivity period in question had already run.42 It therefore challenged FDA's failure to grant final approval of its ANDA.43 In a June 2004 ruling, the court denied Apotex's motion for a preliminary injunction and granted the government's motion to dismiss.44 Although the written order is sparse, apparently the judge disagreed with the ruling in the paroxetine case, found the statute ambiguous, and concluded that the agency's patent-by-patent approach was reasonable. Two federal judges from the same district court, therefore, ruled differently on the validity of FDA's patent-by-patent approach.45 The D.C. Circuit, however, concluded that res judicata barred Apotex from bringing suit and vacated the lower court's holding on the merits.46 In a more recent case, a third judge in the same district addressed the issue and found FDA's patent-by-patent approach to be permissible. This case involves ANDAs for 40 mg versions of AstraZeneca's Prilosec omeprazole ; . This com39 See TorPharm, Inc. v. FDA, 2004 WL 64064 D.D.C. Jan. 8, 2004 ; written order memorializing oral order and judgment issued on January 2 Court Overturns FDA Decision that TorPharm Must Share Psxil 180-Day Exclusivity, INSIDE HEALTH POLICY Jan. 5, 2004 ; . 40 Apotex, Inc. v. FDA, Case No. 04-5046 D.C. Cir., Notice of Appeal filed Feb. 13, 2004 ; . 41 Apotex, Inc. v. FDA, Case No. 04-5046 D.C. Cir., Judgment, Dec. 17, 2004 ; . 42 See Appeals Court Backs FDA: Purepac Gets Gabapentin 180-day Award, INSIDE WASHINGTON'S FDA WEEK, Jan. 23, 2004 ; , at 3. 43 Apotex, Inc. v. Food and Drug Administration, 1: 04-cv-00605-ESH D.D.C. filed Apr. 14, 2004 . 44 Apotex, Inc. v. Food and Drug Administration, 1: 04-cv-00605-ESH D.D.C., Order, June 3, 2004 ; see Court Split on FDA's Patent-by-Patent Approach to 180-Day Exclusivity, INSIDE WASHINGTON'S FDA WEEK June 11, 2004 ; . 45 See Court Split on FDA's Patent-by-Patent Approach to 180-Day Exclusivity, INSIDE WASHINGTON'S FDA WEEK June 11, 2004 ; . 46 Apotex v. FDA, 393 F.3d 210 D.C. Cir. 2004 ; . The case giving rise to res judicata was TorPharm, Inc. v. Thompson, 260 F.Supp.2d 69 D.D.C. 2003 ; , discussed in section III-A above, which involved the same parties and the same ANDAs. That litigation related to FDA's decision to postpone the effective date of Purepac's certification to the second patent rather than nullify it as TorPharm had argued ; . Although the causes of action were not the same, Apotex effectively accepted in the first case that exclusivity was patent-based and argued in the second case that it was not. See also Appeals Court Says Apotex Cannot Relitigate Fight Over Gabapentin Exclusivity, BNA INC. PHARMACEUTICAL LAW & INDUSTRY Dec. 31, 2004 and prempro.

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