WASHINGTON _ The House passed a package of legal reformbills last week, including securities litigation reform and productliability reform, that could offer relief to struggling biotechnologycompanies and drug makers. But the bills, core elements of theRepublicans' Contract with America, face certain revision andpossibly legislative death in the Senate.

Securities litigation reform, designed to discourage "frivolous"lawsuits against companies whose stock prices drop, is expected toface tough opposition from lobbying groups representing triallawyers and consumers. Another threat to a sweeping overhaul of thesystem looms at the White House, where President Clinton hassignaled that radical changes may be rejected by veto.

As a result, Senate leaders will be under pressure to craft bills moremoderate than those produced in the House.

Certain elements of the House securities litigation bill, such as acontroversial "loser pays" provision, have been sharply criticized forweakening the ability of ordinary shareholders to sue companies.(See BioWorld Today, Feb. 20, 1995, p. 1 and Feb. 13, 1995, p. 1.)Indeed, Securities and Exchange Commission chairman Arthur LevittJr. has weighed in against the idea. Another provision that exemptscorporate executives from liability in cases where they "genuinelyforgot to disclose" material information has also been criticized.

On the product liability reform front, a bill passed by the House lastweek would establish uniform standards for product-liability suits instate and federal courts. Contained within that bill was a provision,known as "the FDA defense," that has long been championed by thePharmaceutical Research and Manufacturers of America (PhRMA).

The FDA defense would exempt drug companies from punitivedamages in cases involving products that have met "the stringentrequirements of the FDA." The defense would not shield companiesthat defrauded or withheld information from the FDA.

"In many states, juries, manipulated by clever lawyers, havesubstituted their views for the FDA's scientific judgment, reversingthe expert agency that has studied the drug in painstaking detail," saida statement issued by PhRMA last week. "But, by definition, acompany that complies with all FDA requirements and furnishes allknown information about a drug has not acted willfully, flagrantly,maliciously or in a grossly illegal way."

While advocating the FDA defense in the legal reform debate,PhRMA has simultaneously argued during the FDA reform debatethat the agency's requirements for drug approval are "the mostrigorous in the world" and thus prevent many potentially life-savingproducts from reaching U.S. consumers.

The so-called FDA defense likely faces tough sledding in the Senate.The Senate version of a product liability bill could be introducedlater this week with debate on the floor scheduled for May.

FDA Publishes Guidelines In Federal Register

The FDA published a spate of final guidelines earlier this monthunder the auspices of the International Conference on Harmonisationof Technical Requirements for Registration of Pharmaceuticals forHuman Use (ICH). Final guidelines, as opposed to draft guidelines,already have been subjected to a period of public comment.

The overarching goal of ICH, supported by regulatory authorities andindustry trade associations alike, is to promote the harmonization ofregulatory requirements among three regions, the European Union,Japan and the U.S. In addition, the ICH process has includedobservers from the World Health Organization, the Canadian HealthProtection Branch and the European Free Trade Area.

On March 1, the following final guidelines were published in theFederal Register and took effect. (Copies of the full text of theseguidelines are available from Executive Secretariat Staff, Center forDrug Evaluation and Research, FDA, 7500 Standish Pl., Rockville,Md., 20855)

A brief overview follows:

* Guideline on Validation of Analytical Procedures: a discussion ofthe characteristics that should be considered during the validation ofanalytical procedures included as part of registration applicationssubmitted in Europe, Japan and the U.S.;

* Guideline on the Assessment of Systemic Exposure in ToxicityStudies: a discussion of "toxicokinetics," a term defined as "thegeneration of pharmacokinetic data in nonclinical toxicity studies orancillary studies to assess exposure";

* Guideline on the Extent of Population Exposure Required to AssessClinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions: an accepted set of principles for thesafety evaluation of drugs intended for long-term treatment of non-life-threatening diseases (the guideline differentiates between clinicaldata on adverse drug events derived from studies of shorter durationof exposure and data from studies of longer duration);

* Guideline on Clinical Safety Data Management: a definition ofbasic terms, such as "adverse event," "adverse drug reaction," and"unexpected adverse drug reaction," plus standards for expeditedreporting, a description of what should be reported and recommendedreporting time frames, among other things;

* Guideline on Repeated Dose Tissue Distribution Studies: aguideline recommending that repeated dose tissue distribution studiesshould not be required uniformly for all compounds and should onlybe conducted when appropriate data cannot be derived from othersources;

* Guideline on Dose Selection for Carcinogenicity Studies ofPharmaceuticals: a discussion of criteria for high dose selection forcarcinogenicity studies of pharmaceuticals. n

-- Lisa Piercey Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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