Legal Issues

The legal affair team of Schering Corporation led by the Joseph C. condor et al sued the food and drug administration for unfair granting of licenses to manufacture of generic drugs.  While the Schering Corporation carries out research on drug manufacture As well as distributes its manufactured drug products, they think that food and drug administration has applied wrongly the regulatory methods of drug manufacture and distribution particularly concerning generic drugs. According to the Schering corporation, they raise the argument on the exclusively rule(s) which are applied in the approval of generic drugs. The issue is whether there is a single exclusive rule which must apply in the determination of generic drug.  The Schering Corporation believes that bioequivalent requirements established in section 355 (j) (B) must be an exclusive regulatory procedure that determines the validity of generic drugs to be manufactured and distributed within the states (OpenJurist.org, 2010).

The Schering Corporation claims that food and drug administration has broadened the definition of Bioequivalent.  They claim that the FDA has done this without following the set procedures and the current protocols of abbreviated new drug application do not comply with the set regulatory acts.  The most overarching issue in their claim against the FDA is the change of the determination techniques of generic drug under the category of ANDA procedure which relies on the drug availability at the site of action rather than its absorption.  The Schering corporation representatives therefore seek to have bioequivalent as defined in section 355 (j) (7) (B) to be used as an exclusive means of validating generic drugs of the pioneer drugs by the FDA. This implies that the FDA would have to use the rate and extent of drug absorption as their references rather than using rate and extent of the availability of the drug at targeted site of action as the means of validating generic drugs (OpenJurist.org, 2010).

Rule
In the case of Schering Corporation and the FDA, its overtly that the law concerning the particularly matter is patenting and competition act of 1984, which is an amendment that became to be called Hatch-Waxman amendment that after a decade became the FDA regulatory act of the 21 U.S.C.A.  355(j)(2)(A)(iv) (West Supp. 1994). It acts as the guide of approving ANDA by setting the requirements that the FDA has to Observe before the approval of generic drugs. The first part of it includes rate and extent of drug absorption as one of the requirement, which should be less significant as compared with the pioneer drug.  On the second part, the act further empathizes on the rate of absorption drug difference as compared with the original drugs in list. It states that rate should be made intentional and be reflected on the drug label while it dismisses the necessity of absorption rate in the determination of its concentration effectiveness in the body as long as there is no significant difference from the pioneer drugs (OpenJurist.org, 2010)..

Analysis
The FDA regulatory rule is clear of the requirements that an organization has to ensure it satisfies in its non-systematic drugs before they are approved. The rule states that the rate and extent of absorption must be at close range of effectiveness as those of the pioneer drug. It excludes use of concentration data in the point of actions as factor of consideration in the approval process.  The FDA establishes different methods of determining bioequivalence of generic drugs (NSEDs) of which absorption is one of them.  They do not rely on just a single methodology, hence an array of techniques are used to evaluate drugs depending on their type or kind. The FDA has been under conflicts with the approval of drugs using the systems set for sometime. For instance, FDA went against Schering Corporation view in 1990 by granting Copley the go ahead to manufacture proventil   generic drug under the claim that section 355 (j) (B)  was by no way the means of determining bioequivalence. There are several sources which are referred to such statement including 21 C.F.R.  320.23, 320.24, 320.53 and 320.57 (1990). They denied the Schering Corporation the opportunity to produce similar generic drugs while at the same time granting this to the Copley. The district court had decided the case of bioequivalence determination protocol between the two parties several in the favor of the FDA.  While in the district court of the New Jersey, the judge favored the decision on the side of the FDA despite of establishing the fact that Schering Corporation FDA had firm ground of its argument.

The regulatory laws of generic  drugs has got long history since the early years of 1960s, and the FDA applies the principles of safety and effectiveness of drugs as the core determining factors of approving generic drugs. Considering the main composition of determining bioequivalence in the 1970s, the FDA included two terminologies in its generic drug regulation.  Bioequivalence and bioavailability were essentials terms which were included in the law as defining factors of generic drugs under the consideration ANDA. These are affirmed by two federal rules under section 57, number 17,950 and 17,972.  This has been mandated to the FDAs task as the implementation body of laws and regulations concerning food, drugs and cosmetics. We therefore recognized several other regulatory rules that apply to the regulation of generic drugs introduction to the market that were formulated by the congress. The permission from the congress to let the manufacture generic drugs was meant to reduce the cost of drugs while ensuring safety and maintaining quality of pioneer drugs (OpenJurist.org, 2010)..

Conclusion
While relying on the revealed information for the case of Schering and FDA, the application of the regulatory section 355(j) (7) (B) by the FDA was a measure taken limit the chances of market entry for companies which are not compliant with set standards as per the pioneer drug.  The insistence to perform tests both on bioequivalence and bioavailability was all intent to ensure that those manufacturers permitted to produced generic drugs only did so under the specified quality standards.  The   FDA therefore went against the Schering Corporation claim that bioequivalent was an exclusive rule that depended on the rate and extent of absorption, but not bioavailability which tries to incorporate the rate and concentration.  

The interpretation of bioequivalence as depending on absorption only by the Schering Corporation debases their claim on the FDA. The district courts thus  grants FDA side the favor,  because its the body bestowed with the regulatory work, and the section 355(j)(7)(B) does not restriction them  to limited means of tests. They further find out that Schering Corporation claims are not based on infliction on unfair market competition as required by the law. Thus, the corporation loses in the case due to lack of accusation relevancy. The Corporation claim on ambiguity of the bioequivalence definition could have placed them in better position of winning the case however, such an opportunity is always diminished by the courts habitual practices that demand the favor of the body with authority.