FDA Prescription; Bill's Fast Track

July 28, 2016 at 4:25 p.m.

By GARY GERARD, Times-Union Managing Editor-

I was happy to see the President Clinton's administration put some cancer drugs on a fast track for approval.

The program was announced last week. It could cut one to three years off the time necessary for testing around 100 cancer drugs now in development.

It could also cut in half the 12 months the Federal Drug Administration usually spends deciding if a cancer drug is ready for sale. And it allows dying Americans special access to cancer therapies approved in Australia, Canada or Europe, even if they're not on the market here yet.

Here's a quote from the president: "The waiting is over. We cannot guarantee miracles but at least now hope is on the way."

I couldn't agree more. I frankly never understood why we forced dying cancer patients - completely devastated and distraught by their struggle with the disease - to travel abroad to get the last-hope treatment they desired.

Approximately 1.3 million Americans are diagnosed with cancer annually, and about 1 in three will develop it sometime in their lives.

But my question is, what have we been waiting for?

The FDA has offered accelerated approval to other drugs since 1991. The program was aimed at drugs promising hope for any life-threatening disease and was put in place mainly because of an intense AIDS lobby. Instead of requiring drug-makers to prove that the drug prolonged life in hundreds of patients, medicines could be sold after small studies. Then, after the drugs were sold, more extensive studies could be completed.

Eleven drugs have been approved under the 1991 program. Seven of those were AIDS drugs.

Cancer drug-makers were leery of taking part in the program without specific FDA guidelines. Clinton ordered the FDA to provide those guidelines last week, paving the way for the accelerated approval of AIDS drugs.

While I wholeheartedly agree with this order, I can't help but wonder why Clinton waited so long to go ahead with it.

After all, presidential fast-tracking authority over the FDA predates Clinton.

Could it be because just one day earlier a Senate committee passed a comprehensive drug-approval reform package on a 12-4 vote?

While the legislation bears the signature of Republicans bent on deregulation, it also has gained the backing of the American Cancer Society and liberal panel members like Chris Dodd, Tom Harking and Barbara Mikulski.

Did Clinton thrust a moistened finger into the regulatory wind?

Regardless, the outcome is positive for the many cancer sufferers who will benefit, just as the 1991 order was beneficial for many AIDS patients.

But the whole episode points out how the process is driven by politics. Mostly because of vocal AIDS activists, other drugs received fast-track status five years ago.

Cancer just now is receiving that status even though it kills many more people than AIDS.

Why should cancer patients have to compete against AIDS patients for accelerated therapies?

Unfortunately, human pain and suffering appears to have been politicized. Its treatment has been made party to press conferences, political action committees, activists and the latest Hollywood "cause." [[In-content Ad]]

I was happy to see the President Clinton's administration put some cancer drugs on a fast track for approval.

The program was announced last week. It could cut one to three years off the time necessary for testing around 100 cancer drugs now in development.

It could also cut in half the 12 months the Federal Drug Administration usually spends deciding if a cancer drug is ready for sale. And it allows dying Americans special access to cancer therapies approved in Australia, Canada or Europe, even if they're not on the market here yet.

Here's a quote from the president: "The waiting is over. We cannot guarantee miracles but at least now hope is on the way."

I couldn't agree more. I frankly never understood why we forced dying cancer patients - completely devastated and distraught by their struggle with the disease - to travel abroad to get the last-hope treatment they desired.

Approximately 1.3 million Americans are diagnosed with cancer annually, and about 1 in three will develop it sometime in their lives.

But my question is, what have we been waiting for?

The FDA has offered accelerated approval to other drugs since 1991. The program was aimed at drugs promising hope for any life-threatening disease and was put in place mainly because of an intense AIDS lobby. Instead of requiring drug-makers to prove that the drug prolonged life in hundreds of patients, medicines could be sold after small studies. Then, after the drugs were sold, more extensive studies could be completed.

Eleven drugs have been approved under the 1991 program. Seven of those were AIDS drugs.

Cancer drug-makers were leery of taking part in the program without specific FDA guidelines. Clinton ordered the FDA to provide those guidelines last week, paving the way for the accelerated approval of AIDS drugs.

While I wholeheartedly agree with this order, I can't help but wonder why Clinton waited so long to go ahead with it.

After all, presidential fast-tracking authority over the FDA predates Clinton.

Could it be because just one day earlier a Senate committee passed a comprehensive drug-approval reform package on a 12-4 vote?

While the legislation bears the signature of Republicans bent on deregulation, it also has gained the backing of the American Cancer Society and liberal panel members like Chris Dodd, Tom Harking and Barbara Mikulski.

Did Clinton thrust a moistened finger into the regulatory wind?

Regardless, the outcome is positive for the many cancer sufferers who will benefit, just as the 1991 order was beneficial for many AIDS patients.

But the whole episode points out how the process is driven by politics. Mostly because of vocal AIDS activists, other drugs received fast-track status five years ago.

Cancer just now is receiving that status even though it kills many more people than AIDS.

Why should cancer patients have to compete against AIDS patients for accelerated therapies?

Unfortunately, human pain and suffering appears to have been politicized. Its treatment has been made party to press conferences, political action committees, activists and the latest Hollywood "cause." [[In-content Ad]]

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