By Sens. Richard Burr & Tom Coburn

FDA’s go-slow approval approach shortens lives

President Obama recently told the country that regulations have "gotten out of balance, placing unreasonable burdens on business - burdens that have stifled innovation." If the president wants to treat the root causes of declining medical innovation, his administration will have to take a hard look at the Food and Drug Administration (FDA).

We believe some actions of the FDA are eroding America's leadership in medical innovation. Tragically, reduced innovation not only means a loss of scientific expertise, but results in fewer life-improving drugs and devices for patients.

Too often, public attention is focused only on recalled devices or drugs rather than innovative solutions that may have been prevented by the FDA's bureaucratic caution. Sam Kazman of the Competitive Enterprise Institute has outlined how FDA mismanagement can cause "deadly delays" for invisible victims - patients whose names we do not see in the news but whose lives could be improved or extended by a new drug or device.

As an example, he estimates that if the FDA's three-year approval process for a groundbreaking kidney cancer treatment had been accelerated, as many as 3,000 people could have had their lives extended. Unsurprisingly, physicians - who actually deliver health care to patients - share this concern. Surveys of physicians consistently demonstrate that more than two-thirds of physicians think the FDA approval process is too slow.

We need an FDA that embraces a culture that places more primacy on the promotion of patient benefit than the status quo. FDA reviewers need to weigh potential dangers from innovative treatments against the potential life-improving benefits to patients. Too many promising treatments are languishing behind mounting rules that cannot be justified by a focus on safety alone.

The FDA's regulatory malaise harms innovators, too. Today, device companies are launching products in Europe years before they approach the U.S. market. The New York Times recently highlighted the story of a California woman who had to travel to Europe to have a specific spinal device that was manufactured just 40 miles from her home. She could not get the device in the United States because the FDA was still reviewing the product.

A recent scorecard by PricewaterhouseCoopers revealed that the United States ranks seventh out of nine nations in medical-device approval times. Other analyses found that FDA reviews for most medical devices take two years longer than reviews for similar products in Europe, with little or no discernible benefit in patient safety or outcome.

The sluggish development of pharmaceutical drugs is equally concerning. The administration recently announced new "investments" in drug research and development, citing a decline in output from the biopharmaceutical industry. Ironically, government red tape is a primary reason for the decline. New drug approvals must navigate a maze of unwieldy and inconsistent regulations, and they often clear one hurdle only to meet another. As former Health and Human Services Deputy Secretary Tevi Troy recently noted, "the cost and time for new drug approvals [has climbed] to nearly 10 years and a billion dollars."

The combined effect of these trends undermines America's role as the world leader in medical innovation. Faced with regulatory uncertainty, companies increasingly simply give up or leave the United States. This is one reason new drug applications are at the lowest levels in recent memory. Original applications for novel medical devices have plummeted from almost 60 at the beginning of the last decade to fewer than 15 last year.

We do not believe that must be this way. FDA can regain its role fostering innovation, and our country can reclaim its place as the world leader in medical innovation. Here are three suggested areas for bipartisan cooperation this year:

First, lawmakers on Capitol Hill must thoughtfully reauthorize the FDA user fees governing the device and drug industries during this Congress. We stand ready to work with members of the administration and Congress who want to update and strengthen these statutes in a common-sense manner.

Second, Congress should overturn the new medical-device tax that was included in the Patient Protection and Affordable Care Act. If we are serious about "out-innovating" the rest of the world, Congress and the administration should embrace repealing this provision, which will increase costs and reduce innovation.

Third, the FDA recently announced a series of changes to a primary device-approval pathway, the 510(k) process. Many of the changes were a step in the right direction and averted a heavy-handed bureaucratic overreach. Now the FDA is awaiting recommendations prior to its final decisions on a handful of remaining provisions. While we are reserving judgment, we are encouraged by the trajectory and caution displayed in their initial decisions so far.

If recalibrated, the FDA can provide regulatory certainty, free up medical innovation and strike the right balance between potential risks and patient benefit. This is how we win the future for America's patients.

Sen. Richard M. Burr is a Republican from North Carolina, and Sen. Tom Coburn is a physician and a Republican from Oklahoma.

February 16, 2011, The Washington Times