pharmacovigilance

1,300 new hires planned for FDA expansion

Thu, 01 May 2008 06:59:57 -0400

The FDA is hiring some 1,300 badly-needed workers to help with drug reviews and post-approval monitoring activities. Flush with fatter fees from drug developers, the agency says it will recruit biologists, chemists, pharmacologists and more to fill more than 700 new positions as well as 547 recruits for current vacancies. The FDA has been under increasing pressure to beef up its ranks to do a better job at providing timely regulatory oversight for new drugs as well as the safety of therapies already on the market.

The agency is betting that its strategic position at the crossroads of science, regulatory supervision and drug safety--to say nothing of a hefty package of federal benefits--will make it a competitive player in the job market. The FDA will go head to head with drug developers to fill many of these jobs, and that could have a buoyant effect on salaries in the industry.

"Each month, there is a delay in bringing critical staff on board impairs the agency's ability to fulfill this mission," John Dyer, the agency's deputy commissioner for operations and COO, said in a release.

- see the FDA's release
- read the report in USA Today

Millennium spent $1.3M on lobbying

Fri, 08 Feb 2008 06:59:56 -0500

According to public records, Millennium Pharmaceuticals spent $1.3 million in 2007 lobbying the federal government on patent reform and biotech drug regulation. A bill--currently in the Senate--had drawn the ire of pharmaceutical companies. Among other things, the bill calls a reduction in the number of patent infringement lawsuits and the institution of a post-approval patent re-evaluation process. Pharma companies fear that such a law would weaken patent protection. Amgen also spent a chunk of money lobbying against the patent bill.

Millennium also lobbied for legislation that would pave the way for approval of generic biotech drugs. You can bet Amgen wasn't with them on that one.

- see this Forbes article
- read the AP report on Amgen's activities

ALSO: Pharma may be giving big bucks to presidential candidates--$9.1 million so far--but it's surpassed by 16 other industries, according to the Center for Responsive Politics. Report

Related Articles:
Pharma lobbies big-time in '07. Report
Drug lobby stalls pro-generics bill. Report
Amgen ups lobbying efforts. Report
Abiomed shells out $100,000 to lobby feds. Report

In speech, Lilly CEO calls for drug monitoring

Wed, 03 Oct 2007 06:59:56 -0400

In a speech at the Cleveland Clinic, Eli Lilly chairman and CEO Sidney Taurel (photo) called for greater use of health IT in order to monitor the effects of prescription drugs. Not only would such a system provide much-needed post-marketing pharmacovigilance, it would also help the industry study drug effectiveness and identify other indications for drugs. A comprehensive, interoperable health IT could collect detailed data on a daily basis, thus helping doctors, regulators, and drug manufacturers notice trends more quickly. The result would be a more accurate picture of a drug's safety and efficacy than exists today.

"The use of prescription medicines always will be a matter of balancing benefits and risks," Taurel said. "Fortunately, systems are now within our grasp to more quickly identify both the true benefits and the full extent of risks associated with medicines in widespread use."

- check out the release on Taurel's speech

ALSO: The FDA has posted a letter on its website warning Lily to stop making "false and misleading" claims about its antidepressant Cymbalta. Report

Related Articles:
Lilly developing biotech drugs the old-fashioned way. Report
Pharma, FDA to study adverse events. Report
Bickering may stall trial database. Report

FDA expert wants Avandia withdrawn

Mon, 30 Jul 2007 06:59:57 -0400

The FDA's David Graham says that GSK's Avandia should be pulled from the market due to safety concerns. The safety expert made a presentation at today's committee hearing on the therapy that outlines the cardiovascular risks associated with Avandia while noting that the rival diabetes drug Actos does not raise risks. He topped that off by observing that Avandia has no unique short-term benefits and no demonstrated long-term benefits. It remains to be seen if another blow can knock Avandia out of the market--or if FDA officials will listen to what Graham has to say. Any new regulatory move against Avandia would be a big blow to Glaxo, which has seen the market for its blockbuster therapy wither as new reports come out illustrating health risks linked to the therapy.

- here's the article from The New York Times

Related Article:
Docs shunning Avandia in wake of safety study. Report
Researchers raise new warnings about Avandia. Report
Avandia risks exposed under deal to post data. Report
Diabetes expert issued harsh Avandia critique in 2000. Report

CollaGenex touts Phase IV Oracea data

Thu, 01 Feb 2007 19:01:34 -0500

CollaGenex Pharmaceuticals says that a post-approval study of Oracea in combination with Galderma Laboratories' MetroGel skin treatment demonstrated a significant advantage over the MetroGel therapy combined with a placebo in clearing up rosacea. Volunteers taking the combined Oracea-MetroGel therapy experienced an average 66.4 percent reduction in skin inflammation compared to a 48.2 percent average for MetroGel combined with a placebo. After dropping MetroGel from the combinations, the Oracea group continued to maintain their improvement while the placebo group worsened. Oracea was approved by the FDA last May.

- see the release on the results
- here's the AP report on the trial data

Related Article:
FDA OKs Oracea for rosacea skin condition. Report

FDA seeks $87M in fees for drug safety work

Thu, 11 Jan 2007 19:01:37 -0500

The FDA is looking for Congressional approval to assess more than $87 million in new drug company fees so it can hire up a new group of regulators to help manage the agency's post-approval supervision of drugs. That would bring the total amount raised by the prescription drug user fee to close to $400 million. The agency says it's time to modernize, with more supervision for television advertising as well as safety. Sen. Charles Grassley (R-IA) said the money was a step in the right direction but that the FDA really needs to be reformed in order to tackle drug safety appropriately. Senator Grassley has become an untiring critic of the FDA, but his proposals aren't always acted on.

- see that the FDA has to say on the request
- read the report on the regulatory move from the Miami Herald

Related Article:
FDA, drug industry re-negotiate user fees. Report

FDA, drug industry re-negotiate user fees

Mon, 20 Nov 2006 19:01:35 -0500

The pharmaceutical industry is in the process of negotiating the fourth version of the Prescription Drug User Fee Act (PDUFA) with the FDA, as the current agreement is due to expire at the end of 2007. The biggest proposed change would be for drug companies to pay additional fees that would be used to fund post-marketing drug safety studies. "Until now, user fees paid by firms have primarily been used to review the safety and efficacy of new drugs before they are approved to be sold on the market," notes In-PharmaTechnologist. But in the wake of the Vioxx disaster, post-marketing studies--which are used to determine the long-term effects and unanticipated complications from a drug--have received renewed attention. A recent study found that two-thirds of the post-approval drug trials promised by drug developers have never been started despite the fact that developers promised to undertake the studies in order to gain an approval.

In addition to new fees to fund post-marketing studies, the FDA has reached a deal with drug companies that will require the industry to pay fees for the agency to review TV ads. The money will be used to hire new staffers in order to speed the review process. Both Health and Human Services and Congress must agree to the deals before they can take effect.

- read this report from In-PharmaTechnologist
- check out the Wall Street Journal article (sub. req.)

Related Articles:
Report faults FDA's post-marketing vigilance. Report
Analysis shows post-marketing studies ignored. Report
Pharmacovigilance Grows in Importance. Report

New push on for FDA reform legislation

Wed, 15 Nov 2006 19:01:36 -0500

Senator Ted Kennedy is set to ratchet up the pressure for FDA reform at a Senate hearing today. The move is aimed at pushing reform legislation that would mandate new post-approval studies as well as give the agency more authority to update drug labels. Lawmakers are also likely to hear plenty of calls for new funding support for the FDA.

- here's an article on Kennedy's plans from The Boston Globe

PLUS: FDA Deputy Commissioner Scott Gottlieb has been calling for drug developers to pay higher fees so that more resources could be channeled to tracking a drug's safety once it hits the market. Report

ALSO: It started with a controversial video and ended with the victory of Democrat Claire McCaskill in Missouri. But as William Saletan at Slate observes, the biotech industry's impact on politics will have wide-ranging effects in the coming years. Report

Related Article:
Draft proposals open path to experimental drugs. Report
New rules could relax standards for Phase I drugs. Report

Editor's Corner

Sun, 24 Sep 2006 20:01:39 -0400

Last week's hard-hitting report on the FDA by the Institute of Medicine lays out several common-sense reforms that should be embraced wholeheartedly by the biotech industry--if for no other reason than avoiding the backlash over drug safety that the report represents. First, the days when a drug developer could ignore post-approval safety studies are over. I think most everyone realized that already. Serious limitations should be placed on marketing new therapies and mandatory posting of clinical trial data is an absolute must. I think most in the industry would also welcome an increase in budget and staffing at the FDA. It's also clear--and encouraging--that the FDA evidently recognizes that business as usual won't pass muster with the public. The alternative--more stonewalling and bureaucratic inaction--is likely to lead to a Congressional backlash that would inflict damaging penalties and excessive bureaucratic controls over the development process. Some balance is going to be required here. We need to improve drug safety while advancing the Critical Path Initiative's goal of streamlining the approval process. For biopharma, it's time to adapt to a new reality and encourage change. - John Carroll

IOM slams FDA, calls for major reforms

Thu, 21 Sep 2006 20:01:38 -0400

In a long-awaited review, the Institute of Medicine has slammed the FDA, saying its drug safety monitoring systems are inadequate and in need of reform, hampered by bad management and subject to incessant internal disputes. A spokesperson at the FDA said that the agency had made significant progress over the two years since the Vioxx debacle rattled the agency, but also recognized that more work was needed.

The report outlines a series of suggested changes that would dramatically alter the regulatory landscape for drug developers. The IOM, for example, says that initial drug approvals should be limited to five years, ads for new drugs should be banned and that the FDA should be given the authority to harshly punish companies that fail to undertake the post-approval safety studies that they agree to.

The Center for Drug Evaluation and Research came in for some of the most caustic commentary. "Every organization has its share of dysfunctions, unhappy staff members and internal disputes," reported the IOM, "but the committee came away from various encounters with C.D.E.R staff and management with a deep concern about C.D.E.R.'s organizational health."

- read the article from The New York Times
- here's the AP's report

Report faults FDA's postmarketing vigilance

Sun, 09 Jul 2006 20:01:39 -0400

A report released by the Department of Health and Human Services found that the FDA doesn't always follow up on the status of marketed drugs. Post-approval studies are used to determine the long-term effects and unanticipated complications from a drug, and almost half of the drugs approved between 1994 and 2004 were required to conduct at least one postmarketing study. But HHS noted that of the 336 annual reports due in 2004, 35 percent were missing or contained no useful data. Additionally, the FDA reviewed only about 30 percent of the reports that were filed. The HHS's report concluded that postmarketing vigilance was not high on the list of the FDA's priorities. In response, FDA acting commissioner Andrew von Eschenbach said, "While we embrace several recommendations for improvement that are outlined in the report, we do not agree that FDA cannot readily identify whether or how timely postmarketing study commitments are progressing."

In the wake of the Vioxx debacle, postmarketing vigilance has taken on a new importance. If the HHS' investigation is accurate, such lapses have serious implications and could leave the door open for another major safety failure.

- read this Forbes report for more

Analysis shows post-marketing studies ignored

Sun, 05 Mar 2006 19:01:38 -0500

A new analysis shows that two-thirds of the post-approval drug trials promised by drug developers have never been started. Only a handful of the trials are designated as delayed because the FDA never actually specified a timetable. In many cases, developers promised to undertake post-marketing studies in order to gain an approval. The FDA has known for some time that it has a problem when developers never begin trials that were agreed to. The new emphasis on pharmacosafety has already prompted the agency to study the situation. It would appear that the hands-off approach of the past will soon become history.

- here's a New York Times article

Expert panel to review potential breakthrough diabetes treatment

Wed, 07 Sep 2005 20:01:39 -0400

An expert panel will meet today to consider whether Pfizer's new inhaled insulin, Exubera, should be given marketing approval. Analysts view Exubera as a test case for how stringent the FDA will be on safety issues in a post-Vioxx regulatory world. Trials of Exubera showed a slight drop in patients' breathing abilities, raising safety concerns about the new drug. Another concern about the drug is that patients have only been studied for two years after beginning treatment, raising fears that there could be unknown long-term health consequences.

For its part, Pfizer is promising to actively orchestrate a vigorous, post-approval study of patients to track any possible negative effect that could occur. Developed by Nektar Therapeutics in San Carlos, California, Exubera is the first of a new class of inhaled insulins to reach an expert panel review. By reducing the need for injections, Pfizer says that the drug presents a major breakthrough in administering effective treatment.

- read this report from the Los Angeles Times for more

ALSO: Bristol-Myers Squibb's potential blockbuster diabetes drug Pargluva is being reviewed this week, although news reports indicate that agency staff have raised questions about potential heart damage. Story