By Allan Maurer

WASHINGTON, DC—Right around the corner, the new President-elect and Democratic Congress face a maelstrom of decisions that will affect the biotechnology industry and the health of us all.

So says James C. Greenwood, president and CEO of the Biotechnology Industry Organization (BIO) in DC, which represents more than 1,200 biotech companies, academic institutions, state biotechnology center and related organizations in the United States and 30 other nations.

Greenwood is intimately familiar with the halls of Congress. He represented Pennsylvania’s Eighth District in the U.S. House of Representatives from January 1993 through January 2005. A senior member of the Energy and Commerce Committee, he was widely viewed as a leader on health care and the environment.

From 2001 to 2004, Mr. Greenwood served as Chairman of the Energy and Commerce Committee Subcommittee on Oversight and Investigation with oversight authority over issues in the full Committee’s vast jurisdiction.

He led hard-hitting investigations into corporate governance at Enron, Global Crossing and WorldCom; terrorist threats to our nation’s infrastructure; and waste and fraud in federal government agencies.

Before that, he served six years in the PA General Assembly and six years in the PA Senate.
The year 2008 started out fairly strong for the biotech industry, he notes.

FDA needs strong leadership
But the lack of IPO exits, the downturn in the economy and the resulting affects have dampened prospects. “It’s obviously tough now for smaller companies without revenue from product sales that are completely dependent on financings,” he says.
But more than the economic downturn faces the new administration and Congress when it comes to biotech issues.

For one thing, the U.S. Food and Drug Administration lacks strong leadership. “The reality is that the FDA has had very brief periods when it had a strong confirmed commissioner in place,” says Greenwood.

“Lately, it’s been led mostly by acting commissioners. We do need a competent, strong FDA commissioner confirmed by the Senate.”

That commissioner, says Greenwood, should understand the risk/benefit analysis of drugs. “We have pushed for a new FDA commissioner and continue to push for it,” he says.

“Administrations tend to fill out a lot of other positions they believe have higher priority. But the FDA regulates something like a quarter of the U.S. economy. Safe food and drugs and medical devices are pretty crucial. So we’ll push hard to accomplish that [getting a new commissioner named].”

Should FDA be divided?
He adds that the organization wants to make sure that “We don’t have someone approved who is hostile to the industry.”

The new President-elect should pick the commissioner himself, Greenwood suggests. “I think Obama is obviously an intelligent guy and hope he picks someone who understands that the job of the FDA is not to push approval for products that are not safe and effective, but that it is important to understand the balance between benefit and risk.”

Greenwood adds that there is discussion about whether or not the FDA might not be better served if its responsibilities were divided.

“Maybe the FDA is too big for one commissioner,” he says. “Maybe food should be separated so that a food commissioner focuses exclusively on food matters and another focuses on the biological and medical device side.”

Concerns about drug safety have led to a slowdown of approvals for new drug applications and greater scrutiny all along the line of experimental drug treatments, which can lead to greatly increasing costs in developing innovative new treatments.

“There is a level of frustration biotech companies have in getting approval at the FDA. Some Congress members think it’s easy to get an FDA approval. It’s not,” Greenwood insists.

The problem is that when there is a widely publicized drug problem such as with Vioxx, “Everyone sees it,” says Greenwood.

“But when there is a slowdown at the FDA, it doesn’t make any news. Patients suffer as a result (by being denied innovative new treatments) and there is a diversion of investment money that means down the line new treatments for childhood leukemia and other diseases are not developed because the money goes into IT or electronics.”

Most people don’t have a clue about the FDA drug approval process, he notes. Thus far, it has been so effective that most people don’t bother to read the folded multi-page instructions and cautions that come with their FDA approved drugs, prescription or over-the-counter.

“The only thing read less than drug labels are bills moving through Congress,” Greenwood says.
“Every day, hundreds of millions of Americans take drugs for cancer or high cholesterol without incident. We all wish we could have risk free drugs, surgery and automobiles, but that’s not reality. Reality is about weighing the risks against the benefits and getting better and better on the safety issue—but that does not mean slower and slower.”

Greenwood points out that “It is important for us to transcend this good guy/bad guy mentality that exists. Congress brings people up from the FDA and browbeats them.

“There is a need for a collaborative attitude among Congress the administration and the industry. All have the same goals of getting new and innovative medicines in the hands of patients and making sure they are safe and effective, despite all of the heated rhetoric.”

Two big issues
Greenwood says two big issues are on BIO’s agenda for the coming administration. They are follow-on biologics (generics). “It’s crucial how much time must elapse before generics can be approved,” says Greenwood.

“We think that should be 14 years. Lots of folks in the generic industry think it should be less. We’re concerned that if the industry does not have enough time to recover its investments, those investments will never be made. That’s a huge issue for us.”

It costs a billion dollars or more and a decade or more to move a drug from inception to FDA approval and marketing, often with the patent clock ticking from the time a company launches. That’s one reason prescription drugs cost so much.

Drug companies have a limited amount of time to recoup the enormous development and approval costs of putting new treatments on the market.
Patent reform is another huge issue for BIO and the industry, Greenwood says.

Patent challenge could be a death knell

Some people in the IT and banking world want to make it easier to challenge patents, he notes.

“That could be a death knell for the industry. If we get investors to overlook the difficulty of getting FDA approval, and get them to overlook the difficulty of getting a fair reimbursement for the eventual product, they have to believe the patent will be upheld from discovery to marketing. Undermining IP protection would be disastrous.”

He also warns that if healthcare reform includes price control on drugs, we may get cheaper drugs today at the cost of innovative research going for nothing because the industry will not be able to attract the huge amounts of investment necessary to move new drugs to the marketplace and save lives.

Greenwood says that when Obama takes office and reverses limitations on federal funding of stem cell research, “We will stand up and applaud him. But we will also note that allowing the National Institutes of Health to fund stem cell research in academic settings in not sufficient to provide actual treatments for diseases.

“That has to be done by the private sector and requires billions of dollars in private capital. The policy sector has to improve the environment for innovation or it won’t get any of it.”

 

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