The Good and the Bad: Changes at the FDA and in the Biotech Industry

by Barbara A. Brenner

Barbara Brenner

Those of us who work for change know that change is never easy. Changes we push for don’t always work out as we would hope, and we have to be prepared to deal with changes that we would rather not experience. In the last few months, there have been both good and—we at BCA fear—bad changes in the world of drug development and breast cancer treatment review and approval.

…………………………………………………………………………………………………

A Brighter Day at the FDA

Let’s start with the good news, since it’s so hard to find that in the world these days. We have a new Food and Drug Administration (FDA) commissioner to replace Andrew Von Eschenbach, the Bush designee who seemed to think that the role of the FDA was to approve drugs and devices for use as quickly as possible without much consideration for either efficacy or safety.

Margaret HamburgThe Senate confirmed President Obama’s nominee Margaret Hamburg to replace Von Eschenbach. Hamburg is the former New York City health chief and a public health expert who worked on policy in the Clinton administration. She has experience dealing with issues ranging from AIDS to bioterrorism. Public health experts and advocacy groups heralded the confirmation. The appointment of Hamburg, if confirmed by the Senate, will give the FDA the leadership it needs to face huge challenges that range from food safety to an overhaul of its drug and device approval process.

…………………………………………………………………………………………………

“…the Obama administration’s selection of Hamburg signals a shift in the FDA from speedy drug approvals to a focus on safety.”

…………………………………………………………………………………………………

People who have followed the FDA for many years believe that the Obama administration’s selection of Hamburg signals a shift in the FDA from speedy drug approvals to a focus on safety. We certainly hope they are right.

Joshua Sharfstein

Obama’s selection of Joshua Sharfstein as FDA’s chief deputy certainly points in the right direction. Sharfstein has a history of challenging the pharmaceutical industry, particularly its push to prescribe drugs developed for adults to children. From 2001 to 2005, Sharfstein was the spokesperson for Representative Henry Waxman, a longtime critic of pharmaceutical industry practices. In this role, Sharfstein advocated for cracking down on off-label drug use and on pharmaceutical company gifts to physicians. At the end of March, Obama named Sharfstein as the acting FDA commissioner pending Hamburg’s confirmation.

Word on the street suggests that Hamburg may focus on the food safety side of the FDA, while Sharfstein’s portfolio focuses on drug and device approval. Finally, patients and consumers may be a priority at the FDA.

…………………………………………………………………………………………………

Changes in the Biotech Industry May Bode Ill for Patients

Roche Genentech Logo

On March 27, Roche Pharmaceuticals, which held a substantial interest in the biotech giant Genentech, completed its acquisition of a majority interest in the South San Francisco company. Is this bad news for patients? Could be.

Roche, a worldwide pharmaceutical giant based in Europe, works like other big pharma companies to develop and market what it hopes will be blockbuster drugs. Genentech, however, is widely regarded as the leading innovator in the development of biotech therapies for breast and other cancers. The biotech firm is highly regarded for its culture of allowing the best minds to work in ways that advance better treatments for patients.

There is grave concern that Roche, clearly interested in the market that Genentech has developed for expensive drugs like Avastin and Herceptin1, will try to impose its culture of drug development on Genentech. In doing so, there’s a real danger it will drive out some of the best researchers in the cancer world and undermine the innovation that has characterized the company’s work to date.

…………………………………………………………………………………………………

“…Roche has no experience dealing with advocates and activists.”

…………………………………………………………………………………………………

From an advocacy perspective, Roche’s takeover of Genentech means that the door currently open to organizations such as BCA to engage on issues ranging from drug pricing to the drug testing process to measuring quality of life for breast cancer patients will likely close. There is no advocacy movement in Europe like the one in the United States, so Roche has no experience dealing with advocates and activists.

It would be great if our concerns about the Roche takeover were wrong. Whatever happens, it’s clear that the current economic environment will lead to more mergers in the pharmaceutical and biotech industries. What that will mean for patients and for the pace of drug development is anyone’s guess, but it’s not likely to be in the best interests of patients. Therefore, the persons in charge at the FDA are critical, and on that score, there is much reason to hope.

1 Roche’s betting on Avastin may have missed the mark. Shortly after the takeover, Genentech announced that its trial of Avastin in early stage colon cancer had failed. “Avastin Falls Short in Test As Colon Cancer Medicine” by Andrew Pollack. New York Times, April 22, 2009.

…………………………………………………………………………………………………

This entry was posted in Articles.