By Jerry Avorn and Aaron S. Kesselheim

As the US National Institutes of Health faces a $300 million budget reduction, it is creating a unit to facilitate the development of new drugs. The National Center for Advancing Translational Sciences (NCATS) envisioned by NIH Director Francis Collins would redeploy resources from the agency’s existing programs to identify discoveries that could be transformed into therapeutic products.

The road that brings treatments from bench to bedside is notoriously bumpy, and recent years have seen a scarcity of transformative medications and novel drug designs. Of the 47 new products approved in 2009–2010, by our count approximately two-thirds were members of an existing therapeutic class or managed their indicated condition about as well as available treatments. We clearly need more and better innovation.

The assumption underlying NCATS is that many potential drug targets or compounds have been identified but are not being adequately exploited, so the new NIH unit would pursue leads that drug companies or investors have overlooked or have chosen not to invest in. NCATS will also facilitate the exchange of ideas about common therapeutic approaches across different conditions by bringing together similarly oriented mechanism-based researchers currently separated in the NIH’s disease-specific institutes.

These plans raise important questions. Are there really many clinically promising compounds or targets that have been discovered but are languishing, neglected, in some laboratory—or that remain unexploited even though their properties are known? This may be true for some antibiotics, since the need for their restrained use makes them potentially unprofitable products for industry to develop. In such cases, the NCATS model could fill an important niche. But for treatments for conditions such as common cancers or Alzheimer’s disease, how likely is it that a new NIH center will be able to develop candidate therapies that armies of smart investigators, drug companies and venture capitalists have all somehow overlooked? It also isn’t clear that a governmental agency will generate more creative decision-making than the time-tested approach of investigator-initiated research.

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By Georgina Kenyon

Insurance companies are stepping up their marketing of damage-protection products to pharmaceutical and life science companies, some say in response to a June report by the US Food and Drug Administration laying out a collaborative strategy to more closely track the quality of goods globally.

In response to increasing regulatory activity, UK-based JLT Specialty, part of the Jardine Lloyd Thompson Group, has begun marketing such ‘nondamage’ products more aggressively this past summer—and they’re dropping their prices.

The price of the insurance depends on a variety of conditions—for instance, the size of the company seeking insurance, the limits bought and the triggers chosen. However, over the past year the cost of coverage has dropped more than threefold, from approximately 5% to 1.5% of the estimated coverage. For example, previously, $5 million could have covered a company worth $100 million, whereas now it costs $1.5 million to cover the same-sized company.

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By Joe Herring

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.

As economic prosperity comes to developing nations, diseases associated with Western lifestyles, such as cancer and diabetes, are crossing borders. Meanwhile, developing countries are quickly becoming consumers of biopharmaceutical products. With the shared burden of disease comes the need to obtain safety and efficacy profiles across worldwide populations in a way that mirrors global disease epidemiology and treatment.

Increasing access to allow for more people to participate will be instrumental in clinical trials of the future. Developed nations are home to just 15% of the world’s population, yet they host three-quarters of all clinical trials. Clinical trials in emerging regions tend to take place in large urban centers where healthcare infrastructure can support research conducted according to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) standards. Compliance to these industry standards will strengthen the safety and quality of the research and increase public confidence in clinical trial participation.

Without further globalization, the pace of medical research would slow substantially. This is largely due to the reality that clinical trials are larger and more complex than they were ten years ago, and Western participation levels have peaked.

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Joe Herring is chairman and chief executive officer of Covance, headquartered in Princeton, New Jersey, USA. Currently, he also serves as chairman of the board of the Washington, DC–based Association of Clinical Research Organizations.

By Sabine Louët

France, still reeling from the Mediator scandal in which the diabetes drug (also known by its generic name, benfluorex) remained on the market until November 2009 despite earlier indications that it carried a risk of fatal heart valve trouble, is contemplating a revamp of its drug approval system. Lawmakers are due to discuss updates to the rules governing disclosures of conflict of interests by experts involved in the country’s drug approval process when the French National Assembly reconvenes at the end of September.

As part of a draft bill reforming the drugs approval and safety system, France may soon require that conflicts are publicly disclosed by directors and experts at regulatory agencies and made available publicly. Failure to do so would now incur sanctions including fines of up to €30,000 ($43,000).

Etienne Caniard, president of Mutualité Française, a federation of most of France’s nonprofit private health insurers, contends that the new rules will have a positive effect. “This proposal will help uncover the sectors where the state has given free rein to the pharmaceutical industry and where it should take its responsibility and regain control, such as continuous medical education,” he says.

To gain a clean start, the new bill also suggests renaming the country’s drug regulatory authority, from the French Health Products Safety Agency (AFSSAPS) to the National Agency for Medicine Safety (ANSM). The legislation would also make the renamed agency’s drug approval committees smaller than before to ensure that only experts with a track record in relevant therapeutic areas are involved. These experts would not be allowed to sit on drug approval committees longer than four or five years, and the decisions made by the committees would be more transparent.

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By Mike May

In an agency-wide e-mail message on 13 July, US Food and Drug Administration Commissioner Margaret Hamburg unveiled a massive reorganization of the regulatory watchdog’s 41-year-old management structure. “The most obvious change you will see,” she wrote, “is that the Agency’s programs, in terms of a reporting chain to me, will be divided into ‘directorates’ that reflect the core functions and responsibilities of the Agency.” In addition to the existing offices, she said the FDA would also create a new Office of Operations as well as a deputy commissioner for Global Regulatory Operations and Policy “focused on grappling with the truly global nature of today’s world.”

For the pharmaceutical industry, the most important change could be the addition of the Office of Medical Products and Tobacco, which will be directed by Stephen Spielberg, who will assume the new post by the end of September. Speilberg is tasked with helping to coordinate work across the FDA’s centers for drug, biologics, medical devices and tobacco products. In the past, each of these centers reported directly to the commissioner.

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