Press

Seattle Post-Intelligencer

Necessary drugs should cost less

Jay Inslee
27 June 2007

All men are created equal. But all drugs are not. That's why Congress should update the law and allow expansion of generic biologic drugs in a way that maintains safety and incentives for new technological development.

We all support the goal of reducing cost and increasing availability of cutting-edge medicines by establishing a process for the U.S. Food and Drug Administration to approve generic biologic drugs, also known as follow-on biologics. A process is in place for synthetic drugs, but not biologics.

Made from living organisms, biologics offer hope to such people as Winnie Corral, a constituent from Everett with rheumatoid arthritis, who didn't have success with conventional treatments. She started taking a biologic called Enbrel several years ago and recently said she now makes plans without worrying if she'll be in a wheelchair.

Biologics have been a godsend for patients with a range of ailments, from cancer and neurological disease to diabetes and psoriasis. But those complex drugs can cost thousands of dollars per month.

In coming weeks, Congress will consider FDA legislation and may address the issue of cheaper follow-on biologics. This debate is important to us in Washington because our state is home to many of the pioneering biologic companies that are creating hope for patients, not to mention jobs in the region.

Already this year, several bills have been introduced to set up a process by which the FDA could approve generic versions of biologic drugs. Some measures would get follow-on biologics to consumers quickly, but only by short circuiting the clinical trial process and giving little or no patent protection to creators of those drugs, who take on great risk by pouring significant investments into research and development. Those proposals would endanger consumer safety and future innovation.

That's why I introduced the Patient Protection and Innovative Biologic Medicines Act with Reps. Gene Green, D-Texas, and Tammy Baldwin, D-Wis. Our legislation would create a scientifically sound process for approving less expensive biologics, without compromising the high standards currently used when introducing new drugs or removing the intellectual property protections that give companies incentive to continue making groundbreaking cures.

Because biologics are produced from living cells, rather than by mixing chemicals to create a standard product like traditional pharmaceuticals, each one is different. The human body is sensitive and we never truly know how it will react to the new therapies unless tested in clinical studies. Our bill shortens, but still requires rigorous clinical trials of the essentially new drugs so that possible adverse effects can be detected before products hit the shelves.

Our bill also sets a 14-year data-exclusivity period for companies that make biologics. Because the FDA doesn't have a process for the approval of generic biologics, this puts an end to unlimited exclusive rights for those therapies. The time frame is based on current protections for synthetic drugmakers -- where a balance has been struck between lowering costs for consumers and maintaining incentives for innovators.

I will push for the creation of a process to speed the approval of follow-on biologics, with high standards for safety and fair standards for innovators. Doing so would ensure that more patients get access to these life-saving and life-changing therapies at a more reasonable cost.

U.S. Rep. Jay Inslee represents the 1st Congressional District in Washington state. He serves on the House Energy and Commerce Committee, which has jurisdiction over public health issues and the FDA.