Opinion ID: 1403899
Heading Depth: 1
Heading Rank: 4

Heading: fda regulation

Text: Congress created the FDA to protect consumers from dangerous products. United States v. Sullivan, 332 U.S. 689, 696, 68 S.Ct. 331, 335, 92 L.Ed. 297 (1948). In its role as both a health promoter ... and ... a public protector, the FDA employs a comprehensive scheme of premarket screening and post-market surveillance to ensure the safety and efficacy of all licensed medications. 50 Fed.Reg. 7452 (1985). Before licensing a new medication, the FDA employs an extensive screening mechanism to ensure that the potential benefits of the product outweigh any associated risks. The manufacturer initiates the review by submitting an Investigational New Drug Application (IND), containing information about the drug's chemistry, manufacturing, pharmacology, and toxicology. See 21 U.S.C. § 355(b)(1) (Supp. 1991); 21 C.F.R. § 312.21 (1990). If the FDA approves the IND, the drug's sponsor may gather data on clinical safety and efficacy needed for a New Drug Application (NDA), the formal license application. The NDA must include very detailed reports of all animal studies and clinical testing performed with the drug, reports of any adverse reactions, and any other pertinent information from world-wide scientific literature. 21 U.S.C. § 355(b) (Supp. 1991); 21 C.F.R. § 314.50 (1990). The new drug approval process can require years of testing and review. By the time an NDA is submitted, it often consists of thousands of pages of material describing studies of the drug in several hundred to several thousand patients. See 47 Fed. Reg. 46626 (Oct. 19, 1982). The FDA carefully scrutinizes the data supporting the NDA, requiring substantial evidence consisting of adequate and well-controlled investigations. 21 U.S.C. § 355(d) (Supp. 1991). The application is reviewed by physicians, pharmacologists, chemists, microbiologists, statisticians, and other professionals within the FDA's National Center for Drugs and Biologics who are experienced in evaluating new drugs. 47 Fed. Reg. 46626 (Oct. 19, 1982). Recommendations by those professionals are then reviewed by management personnel within the National Center for Drugs and Biologics before the FDA makes a final determination to approve or reject the new drug application. Id. Elaborate premarket screening, however, does not ensure review of approved prescription medications where adverse reactions may appear after extensive preapproval testing. For this reason, the FDA also conducts extensive post-market surveillance. All reports of adverse drug reactions (ADRs) must be reported to the FDA, regardless of whether the physician, the manufacturer, or others believe the reaction to be drug-related. 21 C.F.R. § 314.80(b). The manufacturer must also periodically submit reports as to what actions it took in response to ADRs and must submit data from any post-marketing studies, reports in the scientific literature, and foreign marketing experience. 21 C.F.R. §§ 314.80(b), .80(c). The FDA has authority to enforce these reporting requirements; any failure to comply may subject a manufacturer to civil and criminal penalties. 21 U.S.C. §§ 332-34 (1972 & Supp. 1991). In response to its surveillance findings, the FDA may require labeling changes or if necessary withdraw NDA approval and thereby revoke the license to market the medication. Id. at § 355(e). We find this extensive regulatory scheme capable of and appropriate for making the preliminary determination regarding whether a prescription drug's benefits outweigh its risks. The structured follow-up program imposed by law ensures that drugs are not placed on the market without continued monitoring for adverse consequences that would render the FDA's initial risk/benefit analysis invalid. Allowing individual courts and/or juries to continually reevaluate a drug's risks and benefits ignores the processes of this expert regulatory body and the other avenues of recovery available to plaintiffs. We note that the Utah Legislature has recognized the value of the FDA approval process and the public interest in the availability and affordability of prescription drugs by restricting the extent of liability for injuries resulting from the use of those drugs. Utah Code Ann. § 78-18-2(1) (Supp. 1990) states that punitive damages may not be awarded if a drug causing the claimant's harm: (a) received premarket approval or licensure by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Section 301 et seq... . This policy, designed to avoid discouraging manufacturers from marketing FDA-approved drugs, applies even to drugs marketed with inadequate warnings. The legislature has also acknowledged the important role of governmental standards in Utah Code Ann. section 78-15-6(3). [7] In that section, the legislature declared that there is a rebuttable presumption that a product which fully complies with the applicable government standards at the time of marketing is not defective. [8] Our prior case law supports this approach as well. In Barson v. E.R. Squibb & Sons, Inc., 682 P.2d 832 (Utah 1984), we addressed the sufficiency of evidence for a claim that a drug manufacturer negligently failed to warn of risks associated with its product. We held that even after meeting governmental requirements, if there are dangers about which the drug manufacturer knew or should have known, the manufacturer may be subject to liability. Id. at 836. Thus, consistent with our holding in this case, if a manufacturer knows or should know of a risk associated with its product, it is directly liable to the patient if it fails to adequately warn the medical profession of that danger. Id. at 835. Moreover, the standard in Utah to which drug manufacturers must adhere to establish an adequate warning is very strict. In Barson, we stated: In determining whether a manufacturer has breached that duty [to adequately warn] and the extent to which a manufacturer is required to know of dangers inherent in its drug, it is important to point out that the drug manufacturer is held to be an expert in its particular field and is under a continuous duty ... to keep abreast of scientific developments touching upon the manufacturer's product and notify the medical profession of any additional side effects discovered from its use. The drug manufacturer is responsible therefore for not only actual knowledge gained from research and adverse reaction reports, but also for constructive knowledge as measured by scientific literature and other available means of communication. Barson, 682 P.2d at 835-36 (emphasis added).