The University of New Hampshire Law Review


Christina Scott


The United States Food and Drug Administration has evolved over the past century to regulate new medicine and protect the public from harmful or ineffective drugs. Drug development and testing science have advanced rapidly alongside the FDA’s increased regulation, enabling pharmaceutical companies to assess a drug's potential adverse reactions by studying its reactivity with various proteins called "off-target receptors." Off-target proteins are often screened and reported in the Investigational New Drug Application as a percentage indicating the drug's binding strength to each protein, which suggests the strength of a particular adverse drug effect. Adverse drug effects often lead to unfavorable side effects of a drug.

The in vitro testing of Investigational New Drugs, which is conducted during the preclinical phase of drug development, is not currently regulated. Large pharmaceutical companies are not required to provide secondary pharmacology screening information in preclinical reports if they decide not to test a particular protein or receptor. This lack of regulation can have serious consequences. Insufficient knowledge about a drug's interaction with certain body proteins during the clinical trials stage can lead to unexpected adverse effects or even abandonment of the drug. By requiring regulation for these investigations, the drug development process could be made more effective, economical, safe, and potentially more efficient. With more standardized and comprehensive preclinical testing, companies may have more confidence in their products by the time they are ready for human testing. Regulating these studies can also help to reduce the high rate of attrition in drug development, as potential issues can be identified earlier in the process. Ultimately, regulating in vitro testing can help ensure that approved drugs are as safe and effective as possible while also benefiting pharmaceutical companies by providing them with more reliable and comprehensive data to inform their decision-making.

Repository Citation

22 U.N.H. L. Rev. 483 (2024).