Biotech Values

[HobGlobulin]

Looking Forward to an Unstrapped FDA

http://tinyurl.com/59jfwd

>> Slow and steady upends the race: Strapped FDA has delayed several new drugs, distressing revenue-hungry industry [Chicago Tribune]

Oct. 30--Stepped-up scrutiny by federal regulators is holding up the release of a string of drugs to treat such common ailments as high cholesterol and osteoporosis.

At least 10 drugs for treating a range of ailments from rheumatoid arthritis and heart disease to diabetes and acid reflux have been delayed or shelved indefinitely in the last three months, according to information compiled by the Tribune and disclosures by drug companies, including North Chicago-based Abbott Laboratories and Deerfield-based Takeda Pharmaceuticals North America Inc.

Such delays can be problematic for consumers because they may not be getting the best treatment for their ailments, drugmakers say.

Although drug companies will not say how the delays will affect sales, new revenue is needed in an industry hampered by the economic downturn and myriad expiring patents and competition from cheaper generic drugs.

A report from research firm IMS Health announced Wednesday that the U.S. market for prescription drugs is expected to grow 1 percent to 2 percent, or between $287 million and $297 million this year. That is down from a projection earlier this year of 2 percent to 3 percent.

The FDA delays come on the heels of criticism over the agency's perceived lax oversight of drugs, most notably Vioxx. The arthritis pain pill was on the market for several years before a study showed Vioxx was linked to an increased risk of stroke and heart attack, forcing Merck & Co. in 2004 to withdraw the product used by millions.

The Vioxx imbroglio and other high-profile cases contributed to changes at the FDA last year.

"The new safety responsibility is causing them to re-evaluate applications when they come in and ask further questions that might not have been asked two years ago or so because of these new safety provisions," said Alan Goldhammer, vice president for scientific and regulatory affairs for Pharmaceutical Research and Manufacturers of America, a Washington lobby for drugmakers. "It's clearly unfortunate. That does cause concern for us and ultimately patients as well."

Reviews usually take 10 months after applications are submitted. In the past, the FDA met its approval goal 90 percent of the time, the agency and the lobbying group said. Now, the FDA is getting drugs approved on time 75 percent to 80 percent of the time.

"There is a new process we are working through, but hopefully this is a blip in the system," said Dr. John Jenkins, who heads the FDA's Office of New Drugs.

The FDA blames the lag time on a still-understaffed agency's ability to deal with new duties imposed by Congress and signed into law by President George W. Bush last year.

"There have been dramatic increases in workload that have not kept pace with increases in staffing, and that is one underlying issue," Jenkins said.

Despite the delays, Abbott's cholesterol drug TriLipix and Takeda's experimental proton pump inhibitor TAK-390MR and diabetes pill alogliptin are expected to be approved in the coming months. The companies said the FDA has not requested additional information, a sign there are unlikely safety problems with the drugs.

Jenkins' office has hired 220 people in the fiscal year that ended Sept. 30. But he said those staffers have a learning curve that includes new safety requirements and risk assessments.

"We are optimistic [the additional staffers] are going to help get us back on track," Jenkins said.

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