FDA update

Eschenbach offers 'Andy's Take' on FDA issues

Fri, 04 Apr 2008 07:59:59 -0400

Eschenbach offers 'Andy's Take' on FDA issues

The ever-growing blogosphere has a new voice--none other than FDA commissioner Andrew von Eschenbach. At Andy's Take, Eschenbach offers an unprecedented look into the mind of the FDA's top official, which could give drugmakers and analysts insight into major issues affecting the industry. "I want to give you my take on the changes at the FDA and what we need to do to improve and be responsive to the rapidly changing world around us," states Eschenbach in his inaugural post.

Eschenbach's blog comes at a time when the FDA is under attack from all sides--the agency is dealing with staffing shortages, drug safety, complains about its overly-conservative approach to drug approval, missed PDUFA dates, and an anemic budget. Why is the FDA missing deadlines? What's with all the approvable letters? Why are some promising drugs shot down while others sail through the approval process? We'd all like to know, and it would be great to get feedback from the man himself on these issues.

The first topic Eschenbach tackles is the ongoing heparin dust-up. Eschenbach frankly admits that even if inspectors had examined the right plant (they didn't), they wouldn't have detected the contamination.

"…Our records error on the inspection emphasizes our need to accelerate the improvement of our data systems and computerization of all our records with internal checks and back-up verification…[N]o test we use will ever be 100% reliable, and we cannot rely only on inspections. We need a systems approach to quality that not only enables us to react effectively to problems but enables us to prevent problems by engaging FDA across the entire lifecycle of the products we regulate."

With all the criticism the agency has faced, I'm glad to see Eschenbach take a stab at transparency and attempt to explain just what the FDA's agenda is these days. One hopes that the Commissioner uses this opportunity to provide valuable explanations for the FDA's actions and plans. It will be disappointing if Andy's Take devolves into a just another PR outlet, or a place for Eschenbach to complain about criticism. A frank discussion of the agency's problems will help drugmakers understand the regulatory environment and how it impacts their business. Just don't expect to ask Eschenbach anything directly--readers can't comment on blog posts.

What do you think of the Commissioner's new blog? Email me your thoughts. - Maureen

Canadian regulators forging new biosimilar pathway

Tue, 25 Mar 2008 07:59:55 -0400

While U.S. lawmakers jawbone about a regulatory pathway for biosimilars, or biogenerics, Canada has moved to do it. Health Canada has posted draft guidelines for its regulatory approach to biosimilars. Manufacturers would have to show their products were similar to an existing biologic with interchangeability and substitutability decided on a case-by-case basis. New guidances are being drafted for various product classes.

In the U.S., meanwhile, there have been growing signs that any new legislation on biosimilars could be delayed past the current election year. But in Europe, regulators are busily approving a new slate of follow-on therapeutics.

- check out the report from FDA News
- read the article on the EMEA's approvals in Motley Fool

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FDA designation turns into fast track to nowhere

Mon, 03 Dec 2007 06:59:56 -0500

Life in the biotech fast lane is good for investors, not so great for patients--or so says the Cleveland Plain Dealer after a seven-month investigation of the FDA's record on fast-track drugs. Created in 1998, the fast-track designation was held out as a potential savior for patients with life-threatening illnesses. Helpful drugs could make it to market more quickly, rescuing victims of serious disease.

That's not how it's worked, though. The fast track hasn't increased the number of drugs approved or put them on the market faster, the newspaper concluded after poring over government documents. Instead--in a manifestation of the law of unintended consequences--the designation has lined the pockets of day traders, hedge funds, and executives who get stock options when the FDA shuttles one of their drugs into the express lane.

Meanwhile, many of the drugs in that express lane were subsequently scrapped by their developers, and the FDA only ushered a small number of them onto the market.

- read the report from the Cleveland Plain-Dealer

Related Articles:
EU, U.S. regulators offer single orphan drug path. Report
The FDA: Caught between a rock and a hard place. Report
New drug approval lags in 2007. Report
FDA quick to reject drugs as it gets more cautious. Report
Industry exec says FDA approval process too strict. Report

FDA badly needs more money, staff

Fri, 30 Nov 2007 06:59:54 -0500

It seems that hardly a week goes by without reports of problems at the FDA. And this week is no exception. According to a subcommittee of the Science Board, an independent advisory group, a number of problems plague the FDA. Imports, food inspection, drug manufacturing, and drug development systems within the FDA all need to be overhauled, according to the group's findings. The agency is stretched too thin and it's endangering public health.

"Without a substantial increase in resources, the agency is powerless to improve its performance, will fall further behind, and will be unable to meet either the mandates of Congress or the expectations of the American public," the Science Board was quoted as saying in the Washington Post. "This will damage not only the health of the population of the U.S., but also the health of our economy." The panel recommended modernizing the FDA's computer systems, increasing the agency's funding and increasing participation of scientific leaders. Andrew Von Eschenbach requested the evaluation a year ago.

This year the FDA has endured serious criticism for a number of blunders, including drug safety, food inspection and pet food contamination. It's clearly under-staffed and under-funded, and these issues are likely to continue and worsen if the necessary changes aren't made.

- see this Washington Post article

Related Articles:
The FDA: Caught between a rock and a hard place. Report
FDA can't guarantee drug safety. Report
Overseas drugmaking goes unsupervised. Report
Poll finds problems at the FDA. Report
FDA offers safety reforms to skeptical lawmakers. Report
IOM slams FDA, calls for major reforms. Report

EU, U.S. regulators offer single orphan drug path

Tue, 27 Nov 2007 06:59:57 -0500

Regulators in Europe and the U.S. have joined together to create a common application form for developers seeking orphan drug status. By making it easier to file the regulators are hoping that they will spur more programs for drugs that treat a host of rare diseases. Between the U.S. and Europe there are more than 55 million people who suffer from more than 6,000 rare diseases. But small markets can translate into small profits, which often leave developers cold to any suggestions for new therapies. This rare cross-Atlantic alliance is aimed at making the field more attractive, while giving regulators a chance to gain from their common experiences.

- check out this release from the agencies

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New drug approval lags in 2007

Maureen Martino — Fri, 02 Nov 2007 10:18:58 -0400

The FDA has suffered no small amount of criticism recently, and, according to the Wall Street Journal, the agency's efforts to protect itself from naysayers have contributed significantly to he low number of new drugs approved in 2007. So far this year, the FDA has approved only 15 new molecular entities (NMEs) and is on track to approve about 18 by December. That's down from 22 NMEs in 2006, 20 in 2005 and 36 in 2004. (This does not include vaccines or sNDAs).

The much-talked-about Vioxx debacle and continuing safety concerns with diabetes drugs and anemia drugs caused the FDA to get cold feet when it came to approving drugs such as Novartis' Galvus and Sanofi-Aventis' Acomplia. "It just indicates to you that when bureaucrats come under pressure, they tend to choose the path of asking for more data, as opposed to approving the drug," noted Schering-Plough's CEO Fred Hassan in a recent interview.

Additionally, for companies looking to launch drugs for diseases that already have treatment options, the FDA has raised the bar significantly. The agency seems to be looking for drugs that go above and beyond current treatment options--not drugs that simply offer patients and doctors another option. However, the FDA claims that criteria for approving new drugs hasn't changed drastically this year, and that each drug is approved or denied based on the merit of its application.

- read the WSJ article for more

Related Articles:
FDA quick to reject drugs as it gets more cautious. Report
Industry exec says FDA approval process too strict. Report
Poll finds problems at the FDA. Report
FDA offers safety reforms to skeptical lawmakers. Report
IOM slams FDA, calls for major reforms. Report
Overseas drugmaking goes unsupervised. Report

FDA, Big Pharma team up on drug research center

Thu, 18 Oct 2007 06:59:56 -0400

In all the hoopla over the new FDA funding-and-reform legislation last month, a key provision was eclipsed--the creation of a new research center paid for by drug makers. The Reagan-Udall Foundation is designed to streamline and improve drug development. But as the Associated Press notes, a research collaboration yoking pharma with the FDA creates an entirely new form of regulator-regulatee relationship--one that might get drugs to market more quickly and more cheaply, but even less safely.

The FDA is fast-tracking nominations to the new center's board, with members slated to be named by October 27. Four of the fourteen members are expected to be pharma executives.

- check out the FDA release seeking nominations for the board
- read the AP's take on the foundation

Related Articles:
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Read more on: FDA news

Report: FDA lax in clinical trial oversight

Fri, 28 Sep 2007 06:59:58 -0400

A new report has found that the FDA does little to protect the safety of patients who participate in clinical trials. Daniel R. Levinson, inspector general of the Department of Health and Human Services, has released a report slamming the FDA's oversight of the trials. The FDA has 350,000 testing sites but only 200 inspectors, some of whom work part time. The inspectors managed to visit less that 1 percent of testing sites. When problems were found at the sites, they were often overlooked by top FDA officials and the FDA rarely followed up with those that were cited for problems. One expert interviewed by the New York Times noted that animal testing has more stringent oversight than human testing in the U.S.

The OIG concluded that the FDA does not have a mechanism to identify all clinical trials and Institutional Review Boards. It also lacks a comprehensive database for tracking its inspections of clinical trials. "Data limitations hinder the FDA's ability to ensure that participants are protected from unreasonable risks," said Levinson. Janet Woodcock, director of the Center for Drug Evaluation and Research, acknowledged there problems with the inspection process and that the FDA is working to address them.

- see the OIG's release on the FDA
- read this article for more

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FDA, Big Pharma collaborate on genetic tests

Thu, 27 Sep 2007 06:59:54 -0400

Seven of the world's biggest drug makers are banding together to create a research consortium that will develop genetic tests that can identify patients vulnerable to dangerous adverse events. Under prodding from the FDA, Pfizer, Roche and others will back a research program that will develop tests for serious liver toxicity as well as Stevens-Johnson syndrome. Their work will go into the public domain, available to anyone wishing to develop a genetic test on that data. The development of pharmacogenetics is considered crucial to a new generation of biotech drugs, which are intended to produce higher efficacy rates among smaller groups of patients.

- check out this release for details on the program
- read the article from The New York Times

Related Articles:
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House passes PDUFA: bill heads to Senate

Thu, 20 Sep 2007 06:59:57 -0400

The U.S. House of Representatives has passed a bill to renew the Prescription Drug User Fee Act (PDUFA), positioning it to be passed by the Senate and signed by the President before the Friday deadline. The PDUFA has to be renewed every five years. Recently FDA Commissioner Andrew von Eschenbach (photo) sent out a memo warning that 2,000 workers could get pink slips if Congress doesn't renew the act by Friday's deadline.

According to The New York Times, "The bill combined several pieces of legislation governing drug industry user fees, new rules involving the disclosure of clinical trial results, money for studies of older medicines, incentives for tests in children and even the conflicts of interest of drug agency advisers." There were, however several highly-debated issues that didn't make it into the bill. Many patient advocacy groups want the FDA to allow severely ill patients to have access to unapproved drugs; the bill passed yesterday doesn't address these concerns. And as anticipated, legislation that would pave the way for biosimilars was not part of the bill--much to the relief of branded drugmakers everywhere.

- see BIO's reaction to the bill
- read the New York Times article

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