Final Word: Political Will is the Backbone of Regulation Enforcement

In the pharmaceutical industry, the potential for harm is high and laws, regulations, and ordinances have been established to minimize risk to the public. Nevertheless, people are often placed at risk through selfish actions, or outright criminal acts. Despite the laws and regulations passed in response to public demand, they often are not enforced. Why? Because sometimes, responsible agencies practice selective enforcement based on political biases. The current reulctance of certain US police departments to enforce immigration laws and the lack of strict enforcement of the good manufacturing practices (GMP) in certain countries are clear examples of this. In other cases, enforcement agencies are rendered impotent by politicians who attack the agencies and create fear. Sometimes politicians reduce agency budgets, thereby physically reducing their ability to enforce laws.

Steven S. Kuwahara , PhD

Agencies charged with protecting pharmaceutical products are often the victims of these budget cuts. Although public announcements describe how various agencies are protecting the public health, in reality, politicians— responding to pressure from their contributors—are quietly reducing the budgets and directing enforcement efforts elsewhere.

The situation, unfortunately, is an international problem. In the US, as well as in other countries, politicians often act to protect businesses, while ignoring the needs of their constituents and the general public. We often hear of the potential economic damage that enforcing the GMP will impose, but the public benefit resulting from GMP enforcement is not discussed. In fact, in several countries, politicians focus only on the worst-case scenarios of full enforcement of GMP or related rules and regulations—companies closing. The consequences to the public of allowing incompetent, ignorant, or willfully noncompliant companies to remain in business are not discussed.

The lack of political will and the resulting betrayal of consumers can create serious problems for biopharmaceuticals manufacturers. The necessity for absolute safety drives regulators to impose greater demands on clinical studies and manufacturing controls. The result is that a few companies will ignore or actively bypass safety requirements. When coupled with the lax enforcement that arises from a lack of political will, the potential for a massive loss of public confidence becomes real.

The seventeenth century poet, John Donne, said, "No man is an island" and "Every man's death diminishes me." In the same sense, every warning letter, every consent decree, and every recall diminishes all of us. We are all a part of the pharmaceutical industry. Unethical or criminal acts do not become acceptable just because they are not officially detected or punished. In the eyes of the public, we are all reduced by every serious adverse event or product related death.

Steven S. Kuwahara, PhD, is a principal at GXP BioTechnology, LLC, 408.430.9338, stevekuwahara@gxpbiotech.org He is also a member of BioPharm International's editorial advisory board.