Clinical Trials News

FDA Approves GlaxoSmithKline's New Combination Vaccine For Children

2008-06-25T14:52:00.000-07:00

Image via WikipediaThe US Food and Drug Administration (FDA) announced yesterday that it had given approval for the first new combination vaccine for protecting 4 to 6 year old children against diphtheria, tetanus, pertussis and polio diseases in one shot, made by GlaxoSmithKline (GSK).

The vaccine is branded as the trademarked name KINRIX, and its official long name is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine.

It is approved for use with children who have already received GSK's Infanrix or Pediarix combination vaccines. Infanrix covers DPT, diphtheria, tetanus and pertussis (whooping cough), and Pediarix covers DPT, hepatitis B and polio.

Health experts tend to recommend combination vaccines because they reduce the number of shots children receive in a single visit.

On Monday, Sanofi Pasteur, part of French drugmaker Sanofi-Aventis SA, announced that the FDA had granted a license for its new 5-in-1 vaccine for use with children under 5 to protect them against diptheria, tetanus, pertussis, polio and Hib disease.

Assistant Clinical Professor of Pediatrics, University of California, San Diego School of Medicine, Dr William P. Hitchcock said in a press statement that:

"Children 4 to 6 years-old can receive five or more vaccinations in a single visit, which can be stressful for parents and vaccinators."

Reducing the number of vaccine shots a child receives in a visit, combination vaccines like KINRIX may help families meet CDC recommendations and school vaccination requirements, he added.

According to GSK, clinical trial results on KINRIX showed that it offers similar protection to the separate vaccines for Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) and Inactivated Poliovirus (IPV), and it has a similar safety profile.

The Phase III trial of KINRIX was the final confirmation. This comprised a randomized controlled study involving 3,156 US children aged from 4 to 6 years who were vaccinated with KINRIX at the same time as receiving their second dose of measles, mumps and rubella (MMR) vaccine (US licensed M-M-RII).

All the children had already received four doses of DTaP (INFANRIX) and three doses of IPV (IPOL).

Director for US Clinical Research and Development/Medical Affairs at GlaxoSmithKline, Dr Wayde M Weston, said that KINRIX contains the same DTaP and IPV ingredients as INFANRIX and PEDIARIX, two vaccines that doctors in the US have used for many years.

"With the introduction of KINRIX," said Weston, "eligible 4 to 6 year-olds can receive protection against four serious diseases with one less shot."

FDA Needs Larger Budget, Agency Science Board Says

2008-02-28T10:39:00.001-08:00

FDA needs an expanded budget of about $375 million in fiscal year 2009 to reverse longtime funding shortfalls, the agency's Science Board subcommittee said on Tuesday, CongressDaily reports. The subcommittee estimated that FDA needs an additional $2.2 billion over five years to bring the agency's funding level to $3.7 billion by FY 2013. In addition, the subcommittee recommended that FDA receive an additional $128 million in food safety funding in FY 2009 and $750 million over five years. President Bush in his proposed budget requested $51 million in additional agency funding, which would bringing total funding to $1.7 billion, with $42 million dedicated to food safety.

House Energy and Commerce Committee Chair John Dingell (D-Mich.) said, "These estimates show that the president's budget has completely missed the mark in terms of what is truly needed to protect Americans," noting that the science board recommendations are seven times Bush's proposed levels (Edney, CongressDaily, 2/27).

In related news, FDA Commissioner Andrew von Eschenbach -- "in an unusual public departure from Bush administration policy" -- said in an interview that he had requested a greater funding increase for the agency than was present in Bush's budget plan. Von Eschenbach also said that the agency needs better organization to oversee drug safety and other issues more effectively. He said, "I think to do what we need to do requires substantially more dollars than what has been invested in the FDA thus far," adding that "there are issues that this agency needs to have addressed and that it's going to have to be transformed" (Wilde Mathews, Wall Street Journal, 2/27).

Postmarket Oversight
Meanwhile, FDA on Tuesday announced a proposal that aims to improve postmarket oversight of prescription drugs, the Wall Street Journal reports. Announced in an e-mail to employees, the "Safety First" plan will create a new database to list the potential side effects of prescription drugs and provide a schedule for following up on questions. The agency also will revise its procedure for making certain regulatory decisions, "particularly those based on emerging safety worries, though the new moves don't go as far as some critics have advocated," according to the Journal. The plan gives new authority to the Office of Surveillance and Epidemiology, stopping "short of divorcing the two functions" of the office, which is to approve drugs and monitor for safety issues after approval, the Journal reports.

Under the plan, the office will:

* Implement multidisciplinary groups, including the premarket approval group and the safety office, to work together to make decisions and allow the groups to make appeals to higher-level officials in instances of disagreement;

* Appoint new, dedicated officials who will be responsible for focusing on safety in each of the divisions;

* Have primary authority to approve drug brand names and labeling; and

* Have the authority to commission certain kinds of research, including requiring drug makers to conduct studies.

The office will not have the authority to approve label changes and to remove a prescription drug from the market. Von Eschenbach said, "What we're doing is to create an integrated approach ... that isn't going to perpetuate problems of the past but really try to embrace what have to be solutions of the future."

In the future, FDA will implement a second phase of the plan, called Safe Use, which will focus on the safety of prescription drugs in real-world settings. However, there are few details available on that plan as of yet, according to an agency official (Wilde Mathews, Wall Street Journal, 2/26).

Congress Likely To Debate Source Of Funds For FDA Oversight Of Direct-to-Consumer Prescription Drug Advertisements

2008-02-26T11:27:00.000-08:00

The FDA budget for oversight of direct-to-consumer prescription drug advertisements in fiscal year 2008 is "larger than the past five years combined," but "whether that level of funding will be sustained and continue to come from taxpayers -- or will be raised from drug makers through new user fees -- is likely to be battled out in Congress," USA Today reports.

In FY 2008, FDA received $6.1 million to determine the fairness and accuracy of DTC ads, compared with $2.2 million in FY 2007 and $1 million in FY 2006. FDA officials said that the agency plans to hire additional employees to review more DTC ads. FDA, which currently has 13 employees who review DTC ads, received materials for 12,616 ads last year.

In his FY 2009 budget request, President Bush seeks $14 million in user fees from the pharmaceutical industry to finance 27 additional FDA employees who review DTC ads. In exchange, FDA would review DTC television ads within 45 days and before the ads begin to air.

The Pharmaceutical Research and Manufacturers of America supports the use of user fees to finance FDA oversight of DTC ads. According to PhRMA, expedited FDA reviews of DTC ads would "help drug makers meet marketing goals and lessen the risk of running ads later cited by the FDA for false or misleading content," USA Today reports.

However, some Democratic lawmakers -- such as House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies Chair Rosa DeLauro (D-Conn.) -- oppose the use of user fees to finance FDA oversight of DTC ads. "Congress should provide a direct appropriation in order to minimize industry influence in the FDA," DeLauro said (Schmit, USA Today, 2/25).

FDA Authority Over Imports
In related news, HHS Secretary Mike Leavitt said that the Bush administration supports a proposal that would expand FDA authority over medications and foods manufactured abroad for distribution to the U.S., the Wall Street Journal reports. In a letter to Reps. Joe Barton (R-Texas) and John Shimkus (R-Ill.), Leavitt wrote that, because companies abroad often can "deny U.S. officials access to their facilities without any adverse consequences," such a proposal "would better enable FDA to address criminal conduct that occurs entirely outside of the United States and threatens the health and safety of consumers within the United States."

Leavitt sent the letter in response to a request from Barton and Shimkus, who have lobbied for such a proposal since 2000. Barton said, "The secretary's support is good news. We have to get this right, and we have to get it right soon because the volume, variety and the complexity of products arriving from overseas is increasing every day" (Zhang, Wall Street Journal, 2/23).

Opinion Piece
The "unfolding tragedy" in which hundreds of U.S. residents experienced severe allergic reactions or died after they received injections of "Chinese-made heparin has its roots in a spectacular example of bad government that some federal watchdogs started barking at a decade ago," but lawmakers "simply did not respond adequately to the warnings," syndicated columnist Terence Jeffrey writes in the Washington Times.

A 1998 investigation conducted by the Government Accountability Office found that FDA "did not possess a complete and reliable list of the foreign manufacturers producing drugs" and that the system "put Americans at risk," Jeffrey writes. In November 2007, GAO presented to the House Energy and Commerce Subcommittee on Oversight and Investigations the results of a recent investigation that found FDA "still did not have a complete and reliable list of foreign factories making drugs," according to Jeffrey.

He concludes, "Will another decade pass before politicians fix the FDA?" (Jeffrey, Washington Times, 2/24).

Unapproved Uses Of FDA-approved Drugs And Medical Devices

2008-02-16T23:51:00.000-08:00

The Food and Drug Administration (FDA) issued a preliminary draft guidance regarding the publication of information related to unapproved uses of FDA-approved drugs and medical devices.

Randall Lutter, FDA deputy commissioner for policy, said "Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care. This guidance also safeguards against off-label promotion."

Section 401 of the FDA Modernization Act had previously set out guidelines that permitted the dissemination of information on unapproved uses of FDA-approved drugs and medical devices. If the manufacturers complied with the guidelines when publishing information they were not seen as an attempt to promote the product for non-FDA approved use (off-label use). As Section 401 expired in September, 2006, new guidelines are needed. Hence the issue of the FDA's "Good Reprint Practice" draft guidance.

The draft guidance recommends principles drug/medical device manufacturers should follow when distributing scientific or medical journal reprints, or reference publications.

They should make sure that the article or reference was/is published by an organization which has an editorial board. All conflicts of interests faced by the organization, as well as biases for all authors, contributors or editors linked with the journal article should be disclosed fully. The article should be peer-reviewed and published in accordance with precise procedures.

Additionally, the draft recommends against distribution of special supplements or articles that have been financed by one or more of the manufacturers of the product in the article, and articles that are not supported by convincing medical evidence are considered false and misleading and should not be distributed.

The FDA will have the legal authority to decide whether an article/publication distribution be classed as promotion for an unapproved new use, or whether such activities cause a drug/medical device to be misbranded or adulterated under the Federal Food, Drug and Cosmetic Act.

The FDA is inviting typed comments, which should be submitted within 60 days of the Federal Register notice announcing the availability of the draft guidance.