Llew Keltner of Novici Biotech discusses ethical issues that biotechnology firms face in the course of developing new drugs and bringing them to market, along with what the FDA can and cannot do to help. Off-shore clinical testing is a standard industry practice that helps to speed development and control costs, but in some countries, according to Keltner, data integrity can be a major area of concern. It is routine, he says, for biotechnology companies to encounter principal investigators who are willing to deviate from the research protocol or outright fabricate data. Managing this reality presents legal, business, and policy challenges. In some countries, reporting unethical behavior to the host government can put the directors of the companies in personal danger. Keltner notes various oddities in current policy, such as the fact that it is legal for a company to comment on off-label use when a drug is in trial, but illegal to comment on off-label use once the drug is approved.

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