Opinion in 2011

The path to drug approval is long, hard and often perplexing. In recent months, the US Food and Drug Administration (FDA) has promised to bolster 'regulatory science', which aims to transform its decision-making process to be more efficient, transparent and accountable. However, diverse stakeholders, including patients, drug developers and the US Congress, will have to rise to the challenge of coordinating their priorities if this endeavor is to succeed.

Ground-breaking science in the area of cannabinoid signaling holds great promise for new drug development, but an unintended consequence of this research has led to the emergence of an onslaught of deadly 'legal highs'. Providing public health scientists with access to laboratory resources designed to investigate emerging chemicals of concern is crucial for timely, sound evaluation of products that pose major threats to public health.

The new National Center for Advancing Translational Sciences planned for the US National Institutes of Health intends to help transform biological findings into new therapeutic products. But if taxpayer funding of risky biomedical research translates into lucrative new medicines, the public should share in the economic benefits as well.

Although the globalization of clinical trials has provided benefits to host countries, critics have focused on the rare but egregious examples of unethical practices. But large, coordinated trials by the contract research industry can encourage best practice, particularly if local countries adopt more consistent standards and oversight.

A recent serious outbreak of Salmonella linked to clinical and teaching microbiology laboratories highlights the dangers of working with laboratory pathogens—but it is probably not an isolated occurrence. Without a better system for reporting infections resulting from laboratory exposures, we risk seeing more of these types of outbreaks.

With an eye to tackling the growing problem of antimicrobial drug resistance, US lawmakers last month proposed new incentives to jump-start the ailing antibiotic industry. But the legislation as written is not likely to have the intended consequences, as it fails to adequately shield companies from competition with generic drugs. To truly entice investment and research from the drug industry, the bill needs to simplify the path to regulatory approval, provide greater protection from generic competition and aid drug companies with intellectual property extensions, tax relief and guaranteed market commitments.

The do-it-yourself biology movement has exploded in recent years, culminating in the formation of the world's first community laboratory, opened late last year. As this grassroots effort continues to grow, professional biomedical researchers stand to benefit from partnering with the legions of garage biotechnology enthusiasts.