The issue of drug safety of imported drug products and active pharmaceutical ingredients (APIs) took center stage this week when the US House of Representatives Committee on Energy and Commerce proposed measures that would require country-of-origin labeling of APIs, parity between foreign and domestic inspections of drug-manufacturing facilities, registration fees to finance the cost of inspections, and annual registration of drug-manufacturing facilities operating in the US or exporting products to the US.

These proposals were initiated in the form of a discussion draft of the Food and Drug Administration Globalization Act of 2008. The discussion draft is designed to stimulate discussion about how to provide adequate funding and authority for FDA to ensure the safety of the country’s drug, medical device, food, and cosmetics supply. The committee plans to hold hearings on the draft over the next several weeks and to mark up legislation shortly.

The debate on how to reform FDA’s inspection process and improve regulatory oversight of the global pharmaceutical supply chain is much needed, but as the saying goes, “The devil is in the details.” In this case, much lies ahead not only in debating the measures themselves but in discussing how these measures would be implemented.

As an example, the discussion draft proposes an annual registration fee for defraying the cost of FDA inspections, but the amount of the fee or a formula for determining a fee is not specified. Instead, the discussion draft proposes that the Secretary of Health and Human Services determine the fee.

The measure also proposes that all drug and device facilities operating within the US or exporting products to the US register annually with FDA. Although this measure is certainly valuable, its viability is tied into FDA’s ability to improve its IT infrastructure, a problem that FDA addressed when assessing its limitations in improving the inspection of foreign drug-manufacturing facilities (see ePT story, “FDA Commissioner Testifies Before Congress on Foreign Inspection Process.”

The discussion draft also proposes country-of-origin labeling for APIs by requiring that drug labels identify the source of the API and its place of manufacture. This requirement raises an interesting point on whether the requirement would apply only to the final API or would it also include intermediates and starting materials used in the synthesis of that API. Sourcing intermediates or starting materials from offshore facilities is a common practice in the industry. Whether country-of-origin labeling would apply only to the manufacturing location in which the last steps of an API synthesis are performed or incorporate the other parts of the supply chain is a potential point of debate.