Editor’s Notes:

This week’s edition contains several articles focusing on the concept of medical innovation and risk: both why it is important to reward risk-taking through free markets, and how innovation can be deterred when America’s civil justice system inflicts damage awards on corporations that are capricious and arbitrary.

Repercussions from the Vioxx withdrawal may be felt for years—both through the ensuing avalanche of litigation against Merck and through an FDA that feels like its every move is being second-guessed by the media and Congress. The FDA may weather the storm and continue its push to utilize cutting edge science to accelerate drug development and improve drug safety, or it could retreat under political pressure and delay reforms until the smoke clears.

It is too early to tell what path the agency will ultimately take, but as this article notes, FDA advisory committee meetings slated for the next few weeks will give the public and industry a preview of how the agency sees its role in the post-Vioxx era:

In the first two weeks of September, FDA advisory committees will review a series of potential blockbuster drugs, including an inhaled insulin called Exubera, to be marketed by Pfizer Inc.; Bristol-Myers Squibb Co.'s Pargluva for adult-onset diabetes; and another Bristol-Myers medicine, Orencia, aimed at treating rheumatoid arthritis. Analysts predict each drug could have annual sales of more than $1 billion if they pass the FDA approval process.

The industry will view the votes as a signal of how deeply a sense of caution on drug approvals has taken hold, particularly in the wake of last week's $253 million court verdict against Merck & Co. over its painkiller Vioxx, which was voluntarily pulled from the market because of concerns about its safety.

"This is really a critical period," said Tom Garvey, a former FDA official who now consults for the drug industry. "It will be very important to see where they set that balance point between benefit and risk."

Diabetes and arthritis are serious conditions that afflict millions of Americans, and new drugs for these diseases are vitally needed. These drugs, however, may be taken long-term by millions of patients and therefore raise the specter of unpredictable side effects that could haunt the agency years after the drugs are first approved.

Rather than delaying new treatments for years in a vain attempt to eliminate all risks, the FDA—and industry—need to remind the American public that medical innovation is always fraught with risks, but the riskiest course of all is to abandon the quest for new cures.