Health Care

Now for the down side of today's news.

Senators agree to 12-year exclusivity period for high-tech drugs

By Associated Press

9:55 PM EDT, July 13, 2009

WASHINGTON (AP) — Senators have agreed to give high-tech biotech drugs a 12-year market monopoly before generic versions can compete.

The Obama administration and the AARP had wanted a much shorter exclusivity period for the high-tech injectable medications used to treat cancer and other ailments. But senators on the Health, Education, Labor and Pensions Committee rejected that proposal.

The votes came as the committee worked to complete work on a sweeping health overhaul bill. The biotech drug portion was a major unresolved issue. It's something Congress has been fighting over for years.

The decision by the Senate's health committee would still need to be agreed to by the full Senate and the House, where lawmakers may try to trim it down to closer to the Obama administration's proposed 7-year market exclusivity period.

More from the WSJ

Blood Boils Over Bill To Protect Biotech Drugs

http://online.wsj.com/article/SB124744245402430031.html?mod=googlenews_wsj#articleTabs%3Darticle

"...........Sen. Kennedy, whose state includes large biotechnology companies and research centers, has consistently advocated the brand-name makers' position, as have some other Democratic health committee members, including Patty Murray (D., Wash.) and Barbara Mikulski (D., Md.).

But some other Democratic senators, including Chuck Schumer of New York and Sherrod Brown of Ohio, as well as the chairman of the House Energy and Commerce Committee, California's Henry Waxman, favor strict limits on brand-name biotechnology products to cut drug costs.

Messrs. Brown and Schumer and Mr. Waxman have introduced separate bills this year, supported by consumer groups, that propose a base of five years' exclusivity, with a possibility of extension.

"Biotechnology start-up involves high risk and high cost, but you can't give these companies open-ended protection from generics," said Sen. Brown in an interview.

A report in June by the Federal Trade Commission rejected the industry's stance and said 12 to 14 years of exclusivity would harm patients by unnecessarily delaying access to affordable drugs. The White House recently wrote lawmakers that it favors seven years.

The Kennedy legislation is expected to go to the Senate Finance Committee, which is driving the health-care overhaul package. Its chairman, Max Baucus, has supported longer exclusivity for brand-name makers. His staff said he wouldn't comment before his bill is released.

Leaders of the health committee are trying to avoid a public showdown over the issue and may not produce a formal proposal until there is more unanimity on their panel, industry representatives and Senate staffers said.

Mr. Schumer, who serves on the finance committee, said he thinks there may be stronger support for lower exclusivity in the Senate as a whole."

Sales in 2008 for the average biologic – not just the blockbusters – totaled over $666 million. That means it takes less than two years for the average brand-name biologic to recoup R&D costs.
                                                                                                                               
So why then are some Senators advocating for a 12-year monopoly period? Good question. The President says this is too long. The Federal Trade Commission says this is too long. Nearly everyone – including insurance companies, patient groups, and consumer groups – say this is too long.

Everyone, that is, except the drug companies. So, let’s be clear: This is a fight between pharmaceutical companies looking to make lucrative profits and patients in need of affordable drugs.

I read in yesterday’s Washington Post how the pharmaceutical industry is spending millions of dollars a day trying to influence the outcome of health care reform legislation.

Millions of dollars a day are spent to prevent generic drugs – affordable medicine –

We can’t let special interests or political maneuvering delay making affordable prescription drugs more available to millions of Americans.

We are on the cusp of a meaningful, fundamental reform of our health care system. We must ensure access to generic drugs – this is part of this historic moment, of real reform.

Dr. Benjamin appears to be a true role model for the revival of primary care medicine.

But nothing will happen unless we fundamentally reform the financing of medical education.  That is not happening. 

So Dr. Benjamin is very sadly a token.  Dr. Satcher, a former Surgeon General, was a passionate advocate of the reform of the financing of medical education eighteen years ago.  Nothing happened.  So, as Yogi Berra stated: This is deja vu all over again.

Democrats often get the symbolism right but not the policy.

Bohdan A. Oryshkevich, MD, MPH

I believe you mean Dr. Regina Benjamin :-)

I believe you mean Dr. Regina Benjamin :-)

No, it was Dr. Satcher, then at Meharry who spoke in the early 1990s about medical student debt, health care reform, and minority medical education at a national forum on the topic.  He was not able to do anything while Surgeon General.

That just shows you the influence of the Surgeon General.  Dr. Koop used the bully pulpit on an issue of prejudice, HIV/AIDS.  In general, Surgeon Generals do not get a lot done.

Bohdan A. Oryshkevich, MD, MPH