From beer summit to drug summit.
Local medical device and drug makers are looking to President Obama to help improve their relationship with the Food and Drug Administration.
The two parties have had a contentious relationship over the years as politics and science collided during the approval process.
Obama made shaking up the agency one of his campaign promises.
Come October, the FDA, which approves and regulates drugs and medical devices, will be working with a $3 billion budget, the largest in its history and 19% higher than the previous year’s funding.
The agency, which also looks at food safety and regulates nutritional supplements, has a new commissioner: Margaret Hamburg.
Hamburg is a former administrator of the New York City health department.
The FDA has faced its share of challenges in recent years, including several high-profile safety scandals and recalls of drugs including Vioxx and Avandia, food-related health controversies, as well as high turnover and low morale.
Under Obama, the agency’s been busy, picking up the pace of drug approvals, newly regulating tobacco as a drug and issuing a flurry of drug safety warnings. The administration also has called for a top-to-bottom review of the agency.
Some OC device and drug officials are speaking up about what they would like to happen.
Irvine-based heart valve maker Edwards Lifesciences Corp. wants to see “balance” from the agency, according to Louis Mazzarese, its chief regulatory officer. Mazzarese said that the FDA needs to protect consumers but not bar access to “important” medical devices and technologies.
Drug and device makers also say that the FDA must use science as the main factor in approving their products, rather than political considerations as some claim it has in the past.
Political Pressures
Historically, the agency’s been “under an enormous amount of political pressure that potentially distorts the ability to make good, solid (science)-based decisions,” said Douglas Ingram, executive vice president and chief administrative officer for Allergan Inc., the Irvine maker of Botox and other drugs.
“With the elections behind us, I believe the single most valuable event that can enhance healthcare and patient welfare over the long run would be that this historically shrill political rhetoric dissipates,” Ingram said.
Ingram calls for a cordial working relationship between device and drug makers and the FDA that focuses on the medical science of drugs and products up for approval.
The FDA said that it’s “a science-focused regulatory agency that makes science-based decisions.”
Device and drug company regulatory officials say they also expect more openness in their dealings with the agency.
“What I’m expecting to see right now,and this is no flash of brilliance on my part,from Mr. Obama is (that) more transparency is the marching order these days” when it comes to the FDA and other parts of government, Mazzarese said.
Mazzarese added any changes made by the FDA need to be “strategic, well thought-out and well-funded.”
Drug Approvals
The FDA has sped up drug approvals as part of its new thrust, including Allergan’s Ozurdex implant for treating back-of-the eye disease. For the first half of the year, the FDA approved 20 drugs, compared with 24 drugs approved in all of 2008 and 21 in 2007.
The FDA said that it wants to work with the industry, academic medical centers, research universities and the National Institutes of Health to accelerate treatment developments, and that it will work to explore ways to shorten the time from approval to reimbursement.
Another OC eye drug maker, Irvine-based Ista Pharmaceuticals Inc., has found that the agency’s become more stable with respect to drug approvals in recent months, Chief Executive Vince Anido said.
“I’d rather have the stability, even though it costs me more money, rather than not having the stability,” Anido said
New FDA rules have caused Ista to incur additional regulatory-related costs. As an example, Anido said the drug maker had to spend an additional $200,000 on preparing an electronic filing for its Bepreve eye allergy drug candidate, which awaits approval.
During the past few years, Ista has faced what Anido calls “really rough patches” with the FDA as it sought approval for some of its drugs, something that he said came about because the agency was normalizing its internal procedures, including electronic filing for drug applications.
Approvals for drugs and devices are primarily handled through the FDA’s Washington, D.C., headquarters, but OC companies report some interactions with the agency’s district office, which overlooks the San Joaquin Marsh in Irvine.
“That office typically is involved in conducting quality system audits of all device companies in the region,” Mazzarese said.
Mazzarese said that FDA headquarters would call in the Irvine district office to do a quality inspection of Edwards’ local manufacturing facility before it makes a final decision on clearing a medical device.
“They are the ears and hands of the FDA in the field to assure that the manufacturing and control that the company is obligated to ensure exists, in fact, does so,” he said.
