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    <recommendedItem id="20100101_19_343"
                     title="U.S. Marshals Seize Unapproved Ozone Generators"
                     score="0.009"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265747316005"
                     
      &lt;p&gt;WASHINGTON  --  U.S. Marshals have seized 77 unapproved ozone generators, valued at almost $76,000 from a California device manufacturer, the FDA announced.&lt;/p&gt;
&lt;p&gt;The devices were advertised as treatments for various conditions, including cancer, AIDS, hepatitis, herpes, and other diseases, but lacked approval or efficacy data to support the claims made on their behalf, an FDA release said.&lt;/p&gt;
&lt;p&gt;The raid came after the company, Applied Ozone Systems (AOS) of Auburn, Calif., failed to respond to a voluntary recall request last December, the agency said.&lt;/p&gt;
&lt;p&gt;The FDA raised concerns that patients using AOS-IM and AOS-IMD devices will consider it an appropriate treatment for an affliction and delay or stop FDA-approved and proven medical treatments. Patients using the devices may risk infection from contamination of the applicator or catheter, the release said.&lt;/p&gt;
&lt;p&gt;The FDA recommended that healthcare professionals and consumers cease use of the devices.&lt;/p&gt;
&lt;p&gt;The agency said it obtained an inspection warrant for the company&apos;s manufacturing facilities after the owner refused to admit FDA inspectors. It said the inspection revealed several breaches of the FDA&apos;s good manufacturing practice requirements for medical devices, which had never been approved in the first place.&lt;/p&gt;
&lt;p&gt;Ozone is an unstable allotrope of oxygen with three atoms, instead of the normal two. Ozone generators produce ozone from oxygen and have consumer and industrial applications, but ozone itself is harmful to the respiratory system, even at relatively low concentrations.&lt;/p&gt;
&lt;p&gt;Instructions with the Applied Ozone Systems devices suggest blowing ozoned air into the rectal and vaginal areas.&lt;/p&gt;
&lt;p&gt;Friday&apos;s seizure was part of a joint effort of the FDA and the California Department of Public Health to remove or prevent unapproved or unsafe medical devices from entering the market.&lt;/p&gt;
&lt;p&gt;A statement on the company&apos;s Web site said the two ozone generator models, which sold for $750 and $1,200 respectively, were no longer available by order of the FDA and California authorities.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20090101_19_1263"
                     title="Senate Bill Would Give FDA Subpoena Power"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Washington-Watch/Washington-Watch/tb/13900?impressionId=1265747316005"
                     
       WASHINGTON, April 24 -- Two high-ranking senators introduced a bill this week that would give the FDA power to issue subpoenas and to detain suspect drug imports at the border. 
              &lt;p&gt; 
              &lt;p&gt;The legislation, sponsored by Senators Charles Grassley (R-Iowa) and Edward Kennedy (D-Mass.), would greatly broaden the FDA&apos;s inspection and enforcement authority.
              &lt;p&gt; 
              &lt;p&gt;Most notably, it would give the FDA subpoena power for the first time. 
              &lt;p&gt; 
              &lt;p&gt;It would also give the agency the authority to detain products from foreign and domestic plants when inspectors believe a product is adulterated or misbranded.
              &lt;p&gt; 
              &lt;p&gt;Currently, the FDA must rely on other agencies, such as U.S. Customs for imported products, to handle the actual seizure of suspect goods.
              &lt;p&gt; 
              &lt;p&gt;The bill would also commission an Institute of Medicine study to examine the FDA&apos;s system for approving medical devices. Such a study is necessary &quot;in light of recent, serious allegations that have been raised by scientists within the FDA regarding the agency&apos;s handling of medical device reviews,&quot; Grassley said in a press release.  
              &lt;p&gt; 
              &lt;p&gt;(See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/11858&quot;target=&quot;blank&quot;&gt;FDA Device Reviewers Allege Agency Coerces Unsound Judgments&lt;/a&gt;)
              &lt;p&gt; 
              &lt;p&gt;&quot;Our legislation is a practical solution to beefing up the FDA&apos;s inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency&apos;s work,&quot; Grassley said.
              &lt;p&gt; 
              &lt;p&gt;To fund the new authority, the bill would levy fees on plant inspections, according to the release.
              &lt;p&gt; 
              &lt;p&gt;It also requires individuals responsible for submitting drug and device applications to certify that the submissions are not false or misleading and comply with applicable regulations.
              &lt;p&gt; 
              &lt;p&gt;Civil and criminal penalties could be imposed for false or misleading certifications.
              &lt;p&gt; 
              &lt;p&gt;&quot;The agency needs additional tools, resources, and authorities to fulfill its mission of protecting the health and safety of the American people,&quot; Grassley said in a Senate floor speech on Thursday.
              &lt;p&gt; 
              &lt;p&gt;The gaps in FDA authority became glaring during the recent outbreak of salmonella from contaminated peanuts. The agency had to invoke a bioterrorism statute to obtain records from the Peanut Corporation of America (PCA), the company at the center of the scandal.
              &lt;p&gt; 
              &lt;p&gt;Earlier this month, a New Jersey distributor of peanut products originating with PCA refused the FDA&apos;s requests for records, forcing the agency to call in U.S. marshals to execute a warrant. (See &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/PublicHealth/13659&quot; target=&quot;blank&quot;&gt;U.S. Marshals Serve FDA Warrant on N.J. Peanut Distributor&lt;/a&gt;)
              &lt;p&gt; 
              &lt;p&gt;The FDA also had to rely on New Jersey officials, acting under a state law, to stop the distributor from selling products linked to PCA.
              &lt;p&gt; 
              &lt;p&gt;In his speech, Grassley accused the FDA and the industries it regulates of having &quot;too cozy a relationship.&quot;
              &lt;p&gt; 
              &lt;p&gt;The FDA has come under fire for its lack of inspections of foreign plants after failing to stop shipments of contaminated heparin from China, which led to allergic reactions, deaths, and a massive recall in 2008.
              &lt;p&gt; 
              &lt;p&gt;(See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/8816&quot; target=&quot;blank&quot;&gt;Chemically Altered Chondroitin-Sulfate Found in Recalled Heparin&lt;/a&gt;)
              &lt;p&gt; 
              &lt;p&gt;Grassley cited a 2008 Government Accountability Office report that found foreign drug manufacturing facilities were inspected at one-fifth the rate of domestic plants.
              &lt;p&gt; 
              &lt;p&gt;(See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/11415&quot; target=&quot;blank&quot;&gt;GAO Finds FDA Skimps on Foreign Drug Plant Inspections&lt;/a&gt;)
              &lt;p&gt; 
              &lt;p&gt;Grassley said that FDA officials estimated that the agency inspected foreign class II device makers every 27 years and foreign class III device makers every six years.
              &lt;p&gt; 
              &lt;p&gt;In 2008, the FDA began stationing inspectors overseas in order to identify potentially unsafe drugs before they reach U.S. borders. Earlier this year, the FDA opened two offices in India as part of an overseas expansion aimed at keeping unsafe drugs out of the U.S.
              &lt;p&gt; 
              &lt;p&gt;(See &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/12502&quot; target=&quot;blank&quot;&gt;FDA Goes Global to Stop Unsafe Food and Drug Imports&lt;/a&gt;)
              &lt;p&gt; 
              &lt;p&gt;The agency recently launched a two-year pilot program to test whether monitoring the entire supply chain of foreign drugs would be feasible.
              &lt;p&gt; 
              &lt;p&gt;Grassley is the ranking Republican on the Senate Finance Committee and Kennedy is the chairman of the Senate Health, Education, Labor and Pensions Committee.
              &lt;p&gt; 
              &lt;p&gt;The senators introduced a similar bill last year but it never came to a vote.
    </recommendedItem>
    <recommendedItem id="20090101_19_1482"
                     title="Democrats Push Medical Device Liability Bill"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Washington-Watch/Washington-Watch/tb/14178?impressionId=1265747316005"
                     
       WASHINGTON, May 12 -- A cardiologist who chairs an FDA advisory panel joined a lineup of witnesses asking Congress to eliminate manufacturers&apos; blanket immunity from lawsuits over faulty medical devices that were preapproved by the FDA.
              &lt;p&gt; 
              &lt;p&gt;&quot;Unanswered questions regarding device safety and effectiveness often remain at the time of FDA approval,&quot; William Maisel, M.D., chairman of the agency&apos;s Circulatory Devices Committee, testified on Tuesday. 
              &lt;p&gt; 
              &lt;p&gt;Dr. Maisel, of Beth Israel Deaconess Medical Center in Boston, said FDA approval doesn&apos;t mean a device won&apos;t malfunction.
              &lt;p&gt; 
              &lt;p&gt;Noting that 10 million patients have these implanted devices, he said, &quot;It is apparent additional consumer safeguards are needed.&quot;
              &lt;p&gt; 
              &lt;p&gt;He testified before a House Energy and Commerce Subcommittee in favor of the Medical Devices Safety Act of 2009, which would provide patients with legal recourse if they are injured by a malfunctioning implanted device. 
              &lt;p&gt; 
              &lt;p&gt;Under an odd twist of U.S. law, drug companies are liable for damages if their products cause harm, but many device makers are not.
              &lt;p&gt; 
              &lt;p&gt;In fact, if a medical device received premarket approval from the FDA, the manufacturer is protected from liability, thanks to a 2008 Supreme Court interpretation of a 30-year-old law making the FDA the final arbiter of device safety.
              &lt;p&gt; 
              &lt;p&gt;In that 8-1 decision (Reigel v. Medtronic), the Supreme Court ruled that if a device received premarket approval from the FDA, individuals injured by the device may not sue the manufacturer for damages. 
              &lt;p&gt; 
              &lt;p&gt;As a result, lower courts threw out 1,400 lawsuits against device makers, according to Rep. Henry A. Waxman (D-Calif.), chairman of the full House Energy and Commerce committee.
              &lt;p&gt; 
              &lt;p&gt;&quot;It is time for Congress to act properly to correct this clear judicial overreach,&quot; added Rep. John D. Dingell (D-Mich.). 
              &lt;p&gt; 
              &lt;p&gt;Drug companies do not enjoy the same immunity. In March, the Supreme Court ruled 6-3 in Wyeth v. Levine that FDA approval of a drug does not shield its maker from lawsuits brought by patients injured by use of the drug.  (See &lt;a href=&quot;http://www.medpagetoday.com/PracticeManagement/Medicolegal/13120&quot; target=&quot;blank&quot;&gt;Supreme Court Tells Drugmakers &apos;Label Is No Shield&apos;&lt;/a&gt;)
              &lt;p&gt; 
              &lt;p&gt;The bill heard Tuesday, sponsored by Rep. Frank Pallone (D-N.J.), would put the two industries on a level liability playing field. 
              &lt;p&gt; 
              &lt;p&gt;No representatives from the device industry were on the witness panel. 
              &lt;p&gt; 
              &lt;p&gt;But Republicans on the committee and a representative from the Advanced Medical Technology Association (AdvaMed) said device companies do not have true &quot;blanket immunity&quot; from legal action.
              &lt;p&gt; 
              &lt;p&gt;They are still subject to criminal penalties in certain cases, Brett Loper, director of government affairs for AdvaMed, told &lt;em&gt;MedPage Today&lt;/em&gt; after the hearing.
              &lt;p&gt; 
              &lt;p&gt;Rep. Nathan Deal (R-Ga.) argued that the majority of state claims are still allowed because the current law shields only device companies that received premarket approval. They account for just 2% of all devices on the market, he said.
              &lt;p&gt; 
              &lt;p&gt;Most devices are approved through a process known as 510(k), which grants approval if a device is &quot;substantially similar&quot; to one already on the market. Their manufacturers are not shielded from liability even if they are identical to products that are.
              &lt;p&gt; 
              &lt;p&gt;Although devices that are shielded from lawsuits represent only a small proportion of the total market, their 10 million owners deserve legal protection in the event a &quot;manufacturer fails to produce a product that is as reliable as it should be,&quot; said Dr. Maisel.
              &lt;p&gt; 
              &lt;p&gt;Democrats on the panel said legislation is necessary because without a risk of liability, makers of the highest-risk devices -- the class III devices which require premarket approval -- have no incentive to report device malfunctions to the FDA. 
              &lt;p&gt; 
              &lt;p&gt;But Republicans on the panel said the bill would stifle innovation because device companies would operate in fear of lawsuits. 
              &lt;p&gt; 
              &lt;p&gt;&quot;No company would ever create a device if one error meant total ruin for the company,&quot; said Rep. Michael Burgess, M.D. (R-Tex.), an obstetrician-gynecologist.
    </recommendedItem>
    <recommendedItem id="20090101_19_2287"
                     title="FDA Approves Seasonal Flu Vaccine"
                     score="-0.005"
                     href="http://www.medpagetoday.com/PrimaryCare/Vaccines/tb/15162?impressionId=1265747316005"
                     
       WASHINGTON, July 20 -- The FDA has approved a vaccine for the 2009-2010 flu season that protects against a trio of expected influenza strains, but the vaccine will not protect against the 2009 H1N1 pandemic flu virus.
              &lt;p&gt; 
              &lt;p&gt;The FDA said the approved vaccine offers protection from &quot;A/Brisbane/59/2007 (H1N1)-like virus, A/Brisbane/10/2007 (H3N2)-like virus, and B/Brisbane/60/2008-like virus.&quot;
              &lt;p&gt; 
              &lt;p&gt;A vaccine for the H1N1 pandemic virus is being developed separately and is expected to be available for clinical tests by late summer. (See &lt;a href=&quot;http://www.medpagetoday.com/InfectiousDisease/SwineFlu/15053&quot; target=&quot;blank&quot;&gt;WHO Says Healthcare Workers Are H1N1 Vaccine Priority&lt;/a&gt;
          &lt;p&gt;
              &lt;p&gt;FDA Commissioner Margaret A. Hamburg, MD, said the approval was &quot;an example of the FDA&apos;s important responsibility to assure timely availability of vaccine to help protect the health of the American public.&quot;
              &lt;p&gt; 
              &lt;p&gt;The six vaccine brand names and manufacturers are: Afluria from CSL Limited; Fluarix from GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; Fluvirin, Novartis Vaccines and Diagnostics Limited; Fluzone, Sanofi Pasteur; and FluMist, MedImmune Vaccines.
              &lt;p&gt; 
              &lt;p&gt;The viruses covered by the annual seasonal vaccine are selected based on analysis of virus samples and infection patterns around the world that are analyzed by the FDA, the World Health Organization, the CDC and other institutions. Those data are synthesized into a best guess that attempts to match the vaccine to circulating flu virus strains.
              &lt;p&gt; 
              &lt;p&gt;The FDA said, however, that there &quot;is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. Even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.&quot;
              &lt;p&gt; 
              &lt;p&gt;Between 5% and 20% of the U.S. population develops influenza each year, according to the CDC. More than 200,000 are hospitalized from its complications and about 36,000 people die.
              &lt;p&gt; 
              &lt;p&gt;Older people, young children, and people with chronic medical conditions are at higher risk for influenza-related complications of the seasonal flu. Vaccination of these groups is critical.
              &lt;p&gt; 
              &lt;p&gt;Additionally, influenza immunization of healthcare personnel is important in protecting them and others from influenza, the CDC said.
        
    </recommendedItem>
    <recommendedItem id="20090101_19_2294"
                     title="FDA Lays Framework for Expedited H1N1 Vaccine Approvals"
                     score="-0.005"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/15170?impressionId=1265747316005"
                     
      WASHINGTON, July 21 -- The FDA will be extraordinarily flexible in evaluating vaccines for pandemic H1N1 influenza, suggested an agency briefing document issued for an upcoming advisory committee meeting.
              &lt;p&gt; 
              &lt;p&gt;On Thursday, the Vaccines and Related Biological Products Advisory Committee will hear about the status of H1N1 vaccine production, as well as the FDA&apos;s plans for evaluating vaccines in time for the fall flu season, when public health officials expect to see resurgent H1N1 infections. 
              &lt;p&gt; 
              &lt;p&gt;It&apos;s expected that at least one vaccine will be available for clinical test by late summer. The National Institutes of Health has said it would like to begin vaccinating certain high-risk groups, such as healthcare workers, by mid-October, which doesn&apos;t leave much time for the FDA to approve a vaccine. (See &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/15021&quot; target=&quot;blank&quot;&gt;H1N1 Summit: October Target Date for H1N1 Vaccine Distribution&lt;/a&gt; and &lt;a href=&quot;http://www.medpagetoday.com/InfectiousDisease/SwineFlu/15053&quot; target=&quot;blank&quot;&gt;WHO Says Healthcare Workers Are H1N1 Vaccine Priority&lt;/a&gt;) 
              &lt;p&gt; 
              &lt;p&gt;Normally, clinical trials are completed before the FDA would even accept an application for a drug or vaccine. But given the perceived urgency of the H1N1 situation, the agency might approve a vaccine based on incomplete or very small studies, according to a briefing document from the FDA&apos;s Center for Biologics Evaluation and Research Office of Vaccines Research and Review.
              &lt;p&gt; 
              &lt;p&gt;In fact, the document suggested, the agency might even waive its customary demands for compelling safety and immunogenicity data.
              &lt;p&gt; 
              &lt;p&gt;The government expects Novartis, Sanofi Pasteur, CSL, and GlaxoSmithKline to supply inactivated H1N1 vaccines to the U.S. market, while MedImmune will produce a live attenuated H1N1 vaccine, according to the document. 
              &lt;p&gt; 
              &lt;p&gt;The FDA said it would like the sponsors of the study to perform double-blind or observer-blinded studies in which patients are administered two doses of the vaccine, 21 days apart. 
              &lt;p&gt; 
              &lt;p&gt;Manufacturers should stratify their patients into four age groups: infants and toddlers, ages 3 to 9, 18- to 64-year-olds, and older than 65. 
              &lt;p&gt; 
              &lt;p&gt;The FDA did not request an adolescent group because those data can be interpolated from the other age groups, the document said.
              &lt;p&gt; 
              &lt;p&gt;It also didn&apos;t specify a study protocol for babies less than six months, because such studies will have to be designed to evaluate the entire series of infant vaccinations.
              &lt;p&gt; 
              &lt;p&gt;The FDA said that 100 patients in each arm of the trials &quot;is sufficient to provide a description assessment of immunogenicity with a reasonable degree of confidence in that estimate.&quot; If a control arm is used, it should contain at least 25 patients.
              &lt;p&gt; 
              &lt;p&gt;The FDA recommended that patients should be followed for six months after the second vaccination to monitor for serious adverse events, and for one year if the second vaccine contains an adjuvant, the FDA said. 
              &lt;p&gt; 
              &lt;p&gt;The vaccine will be considered as having an immunogenic response if: 
              &lt;ul&gt; 
              &lt;li&gt; The lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving seroconversion for H1 antibody should meet or exceed 40%, or 30% for those over 65.  
              &lt;li&gt; The lower bound of the two-sided 95% CI for the percentage of subjects achieving an H1 antibody titer more than or equal to 1:40 should meet or exceed 70%, or 60% for those over 65. 
              &lt;/ul&gt; 
              &lt;p&gt;The FDA will be working with manufacturers and government agencies to coordinate surveillance plans, according to the briefing document. 
              &lt;p&gt; 
              &lt;p&gt;It is expected that the National Institutes of Health will also sponsor some H1N1 vaccine studies, and the agency will present its plan to the advisory panel on Thursday. 
              &lt;p&gt; 
              &lt;p&gt;According to the briefing document, the FDA is considering vaccines from Novartis and GlaxoSmithKline that use dose-sparing, oil-in-water adjuvants to stretch the quantity of the antigen farther. 
              &lt;p&gt; 
              &lt;p&gt;There are currently no licensed influenza vaccines that contain an adjuvant, and if the FDA decides to approve a vaccine with an adjuvant, it would have to issue &quot;emergency use authorization,&quot; which would allows emergency use of products that &quot;may be effective&quot; in preventing serious or life threatening disease.  
              &lt;p&gt; 
              &lt;p&gt;Normally, emergency use authorization is issued when the FDA commissioner determines there are no available alternatives, but in this case, the commissioner could issue the emergency use authorization if there are insufficient supplies to meet the emergency need, according to the briefing document. 
              &lt;p&gt; 
              &lt;p&gt;The advisory panel is not being asked to vote formally on specific questions. It will hear an update from the FDA, an update from the five vaccine manufacturers, and it will discuss the FDA&apos;s trial protocol recommendations. 
             
    </recommendedItem>
</recommendedContent>
