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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_343"
                     title="U.S. Marshals Seize Unapproved Ozone Generators"
                     score="0.01"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265773131010"
                     
      &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="20100101_19_163"
                     title="Obama Pushs for Change on Biologics in Healthcare Bill"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Washington-Watch/Washington-Watch/tb/17996?impressionId=1265773131010"
                     
      &lt;p&gt;WASHINGTON  --  President Obama has signaled his support for renegotiating a provision in the healthcare reform bill to allow generic versions of biologics to hit the market more quickly.&lt;/p&gt;
&lt;p&gt;Both the House and the Senate bills include provisions to establish a pathway that would allow generic companies to have biologics approved. Currently, no such pathway exists. The provisions would offer brand-name biologic companies a 12-year period during which generic companies would be barred from introducing a competing product.&lt;/p&gt;
&lt;p&gt;In a Thursday closed-door question-and-answer session with members of the House, Obama suggested that a shorter exclusivity period might be in order, even though &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/Washington-Watch/15108&quot; mce_href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/Washington-Watch/15108&quot; target=&quot;_blank&quot; title=&quot;Biotech&amp;#8200;Industry&amp;#8200;Flexes&amp;#8200;Muscle&amp;#8200;in&amp;#8200;Biologics&amp;#8200;Debate&amp;#8200;on&amp;#8200;the&amp;#8200;Hill&quot;&gt;Senate&lt;/a&gt; and &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/15336&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/15336&quot; target=&quot;_blank&quot; title=&quot;Week&amp;#8200;7:&amp;#8200;House&amp;#8200;Panel&amp;#8200;Approves&amp;#8200;Health&amp;#8200;Reform&amp;#8200;Bill&quot;&gt;House&lt;/a&gt; committees voted strongly in support of 12-year exclusivity.&lt;/p&gt;
&lt;p&gt;Members of Congress who have biologic companies in their districts  --  such as Rep. Anna Eshoo (D-Calif.)  --  support the 12-year period, arguing that biologics are so complex that it would take at least that long for generic companies to produce so-called &quot;biosimilars.&quot;&lt;/p&gt;
&lt;p&gt;But some, including Rep. Henry Waxman (D-Calif.), have said the long exclusivity period will harm patients who will have to wait years to see cheaper versions of drugs for diseases like cancer and multiple sclerosis. In addition, some argue that if significantly less expensive biosimilars come to the market earlier, the nation&apos;s drug costs would be reduced.&lt;/p&gt;
&lt;p&gt;The Obama administration has signaled his support for a shorter exclusivity period all along, said &lt;span&gt;&lt;span&gt;Katie Huffar&lt;/span&gt;, a spokesperson for Coalition for a Competitive Pharmaceutical Market (&lt;span&gt;CCPM&lt;/span&gt;), a group comprised of generic drug companies, pharmacies, several insurance companies, and other corporations.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&quot;The administration has been saying they think it&apos;s too much,&quot; she said.&lt;/p&gt;
&lt;p&gt;There don&apos;t appear to be any supporters of the 12-year exclusivity period at the negotiating table as members of the House and the Senate work with the White House to hammer out a final bill. What&apos;s more, Waxman, who is the House&apos;s biggest opponent of the long exclusivity period, has a seat at that table.&lt;/p&gt;
&lt;p&gt;A spokesperson for Waxman declined to discuss details of negotiation process.&lt;/p&gt;
&lt;p&gt;However, the powerful pharmaceutical lobby, PhRMA, supports the longer exclusivity period, and it&apos;s unclear what effect shortening the period would have on the deal that PhRMA struck with the White House earlier in the healthcare reform process. Under that deal, the drug companies agreed to support reform if the White House promised to limit the industry&apos;s losses to $80 billion over 10 years.&lt;/p&gt;
&lt;p&gt;Huffar said her group has been assured that biogenerics were not part of the deal.&lt;/p&gt;
&lt;p&gt;&quot;No one on the government side of that deal shook on 12 years,&quot; she said.&lt;/p&gt;
&lt;p&gt;A spokesperson for PhRMA said the deal hadn&apos;t changed as of Friday, and the group issued a statement reiterating its support for the 12-year period.&lt;/p&gt;
&lt;p&gt;&quot;...At least 12 years of data protection is needed to help recoup the significant development costs for biologic innovators and to fund research on future treatments and cures,&quot; said PhRMA senior vice president Ken Johnson in the statement. &lt;/p&gt;
&lt;p&gt;During Thursday&apos;s Q&amp;amp;A with the president, Eshoo told Obama that Congress had already overwhelmingly backed the 12-year exclusivity period, a source familiar with the exchange told &lt;em&gt;MedPage Today. &lt;/em&gt;&lt;/p&gt;
&lt;p&gt;Indeed, the House Energy and Commerce Committee voted 47 to 11 to add the biologics amendment to the heatlhcare reform bill and the Senate Health, Education, Labor and Pensions Committee approved the amendment 16 to 7.&lt;/p&gt;
&lt;p&gt;Eshoo criticized healthcare reform negotiators&apos; willingness to ditch the 12-year period when other pharmaceutical elements of the reform bill seem to be &quot;sacrosanct,&quot; the source said.&lt;/p&gt;
&lt;p&gt;Obama replied that &quot;nothing is sacrosanct,&quot; according to a House aide.&lt;/p&gt;
&lt;p&gt;In a letter to Speaker of the House Nancy Pelosi (D-Calif.) that is currently gaining signatures, Eshoo writes:&lt;/p&gt;
&lt;p&gt;&quot;While so many issues are still left unresolved in the debate over healthcare in both the House and Senate, this is an issue that has had overwhelming support from both sides. Additionally, it is an issue both Democrats and Republicans have found agreement on. Changing language that is virtually identical for purpose of a final agreement would be unheard of in a traditional conference approach.&quot;&lt;/p&gt;
&lt;p&gt;But healthcare reform is not moving along according to tradition. Congressional leaders decided to &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/17812&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/17812&quot; target=&quot;_blank&quot; title=&quot;Congress&amp;#8200;Likely&amp;#8200;to&amp;#8200;Combine&amp;#8200;Healthcare&amp;#8200;Bills&amp;#8200;Informally&quot;&gt;informally combine&lt;/a&gt; the Senate and House bills instead of using the traditional conference approach, which would likely result in a Republican filibuster.&lt;/p&gt;
&lt;p&gt;As of now, it appears that no deal on the biosimilar language has been reached.&lt;/p&gt;
&lt;p&gt;Negotiators are still finalizing details of the healthcare reform bill and are expected send it to the Congressional Budget Office (CBO) in the next few days for a cost estimate.&lt;/p&gt;
&lt;p&gt;Congressional leaders have promised that the bill would be posted for 72 hours before any major vote is taken on it.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20090101_19_2453"
                     title="Cardiologist Backs Medical Device Liability Bill"
                     score="-0.005"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/15387?impressionId=1265773131010"
                     
      &lt;p&gt;WASHINGTON  --  A cardiologist who chairs an FDA advisory committee testified before Congress for the second time in four months to support a bill that would provide patients with legal recourse if they are injured by a malfunctioning implanted device.&lt;/p&gt;&lt;p&gt;Under U.S. law, device companies are not liable for damages if their products cause harm as long as the device received premarket approval from the FDA.&lt;/p&gt;&lt;p&gt;But &quot;FDA marketing clearance or approval of a medical device does not guarantee its safety,&quot; said William Maisel, MD, director of the Medical Device Safety Institute and a cardiologist at Beth Israel Deaconess Medical Center in Boston.&lt;/p&gt;&lt;p&gt;Dr. Maisel  --  who chairs the FDA&apos;s Circulatory Advisory Committee  --  said the FDA does an &quot;exceptional job&quot; of monitoring the safety of medical devices. However, the postmarketing data is an issue. He said it is &quot;simply impossible&quot; for the FDA to continue to monitor the safety of every medical device it has approved.&lt;/p&gt;&lt;p&gt;Maisel delivered similar testimony before a House panel in May. (See &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/Washington-Watch/14178&quot; mce_href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/Washington-Watch/14178&quot; target=&quot;_blank&quot;&gt;Democrats Push Medical Device Liability Bill&lt;/a&gt;)&lt;/p&gt;&lt;p&gt;Sen. Tom Harkin (D-Iowa), who chaired Tuesday&apos;s hearing, agreed.&lt;/p&gt;&lt;p&gt;&quot;No matter how diligently and effectively the FDA does its job, it simply cannot guarantee that no defective, dangerous, and deadly medical device will reach consumers,&quot; Harkin said.&lt;/p&gt;&lt;p&gt;The device company immunity stems from 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;Drug companies do not enjoy the same protection. 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.&lt;/p&gt;&lt;p&gt;So patients who are injured by a faulty medical device often have to cover the costs of their resulting medical treatment. The federal government would foot the bill if patient was covered by Medicare or Medicaid, Maisel said.&lt;/p&gt;&lt;p&gt;&quot;Some might argue that we have two cash for clunkers programs and this is one of them where the government is paying for defective devices,&quot; he said.&lt;/p&gt;&lt;p&gt;But Peter Barton Hutt, a food and drug attorney in Washington, disagreed with Maisel&apos;s view and said the FDA is in a better position to decide the safety and efficacy of a device than a jury.&lt;/p&gt;&lt;p&gt;&quot;FDA is not perfect, but certainly a jury is going to be less perfect,&quot; he said.&lt;/p&gt;&lt;p&gt;Besides, he said, risk is inherent in all medical devices, and small numbers of patient injuries do not mean a device is defective.&lt;/p&gt;&lt;p&gt;&quot;The fact that it hurts someone doesn&apos;t mean there&apos;s a defect. It may save 999 lives, but hurt the thousandth life. That doesn&apos;t mean it&apos;s defective,&quot; said Hutt, who served as chief counsel for the FDA from 1971 to 1975.&lt;/p&gt;&lt;p&gt;Allowing individuals to sue device companies at the state level -- which is what identical bills in the House and Senate would do -- would not improve device safety, Hutt said.&lt;/p&gt;&lt;p&gt;But giving injured patients the ability to sue provides a &quot;powerful incentive to manufacturers to use the utmost care,&quot; Harkin countered.&lt;/p&gt;&lt;p&gt;Sen. Orrin Hatch (R-Utah) argued that exposing device makers to litigation would make the companies, particularly the small companies, afraid to produce new, innovative products.&lt;/p&gt;&lt;p&gt;The witness panel was lacking a representative from the device industry. However, a race car driver from Missouri told the committee how a spinal implant gave him a new lease on life, and urged the committee not to do anything that would stifle such innovation.&lt;/p&gt;&lt;p&gt;In a release, a spokesperson for Advanced Medical Technology Association (AdvaMed) said the bill would not improve patient safety.&lt;/p&gt;&lt;p&gt;&quot;It will create more frivolous lawsuits and increase healthcare costs, and it will make it harder for small medical device manufacturers to invest in promising new technologies,&quot; said Stephen Ubl, president and CEO of AdvaMed.&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=1265773131010"
                     
       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_2339"
                     title="FDA Likely to Approve H1N1 Vaccine In Advance of Data"
                     score="-0.005"
                     href="http://www.medpagetoday.com/PrimaryCare/Vaccines/tb/15230?impressionId=1265773131010"
                     
      GAITHERSBURG, Md., July 23 -- The FDA is likely to approve 2009 H1N1 (swine flu) vaccines before trial data can prove their safety and effectiveness against the virus.
              &lt;p&gt; 
              &lt;p&gt;Approving a vaccine without safety and immunogenicity data is not uncommon, FDA officials said during a daylong meeting of the Vaccines and Related Biological Products Advisory Committee. 
              &lt;p&gt; 
              &lt;p&gt;The committee met to hear updates on H1N1 trials from the FDA, NIH, and the five companies that are applying for FDA approval of pandemic H1N1 vaccines.  
              &lt;p&gt; 
              &lt;p&gt;In fact, the FDA approves seasonal influenza vaccines every year using its &quot;strain change&quot; process, in which it doesn&apos;t require vaccine manufacturers to provide safety and efficacy data. 
              &lt;p&gt; 
              &lt;p&gt;What is different about how the FDA is likely to handle approval for a vaccine for pandemic H1N1, however, is that the agency doesn&apos;t normally approve vaccines while major clinical trials of safety and immunogenicity are ongoing. 
              &lt;p&gt; 
              &lt;p&gt;Norman Baylor, PhD, director of FDA&apos;s Office of Vaccines Research and Review, explained the FDA&apos;s probable decision to go ahead with the simplified approval process, rather than a lengthy new drug application process.
              &lt;p&gt; 
              &lt;p&gt;&quot;We have decades of experience with H1N1, that&apos;s why we feel we can do this with a strain-change,&quot; said Dr. Baylor.  
              &lt;p&gt; 
              &lt;p&gt;Having a licensed vaccine doesn&apos;t mean that an immunization program will kick-off immediately -- that call has to come from the Secretary of Health and Human Services (HHS). 
              &lt;p&gt; 
              &lt;p&gt;But given the prediction that H1N1 infection rates will pick up this fall, immunization programs are likely to begin before safety and immunological data collection is completed. 
              &lt;p&gt; 
              &lt;p&gt;That trial data will begin trickling in during August and continue through early 2010. 
              &lt;p&gt; 
              &lt;p&gt;The World Health Organization (WHO) and the NIH have said they want to start vaccinating people by mid-October.  
              &lt;p&gt; 
              &lt;p&gt;Of the five companies applying for FDA approval -- Novartis, sanofi pasteur, CSL Biotherapies, GlaxoSmithKline, and MedImmune -- only CSL has already started human trials. The Australian company, which provides seasonal flu vaccines to the U.S., inoculated its first human trial participant Wednesday.  
              &lt;p&gt; 
              &lt;p&gt;Meanwhile, the NIH announced it was set to begin clinical trials in the United States of vaccines made by sanofi-pasteur and CSL. 
              &lt;p&gt; 
              &lt;p&gt;Because an immunization program will likely run at the same time as the trial, the FDA said it would issue updates as the trials answer key questions. They include whether two shots are better than one, and how the vaccine interacts with seasonal flu shots.
              &lt;p&gt; 
              &lt;p&gt;&quot;That&apos;s the harder decision -- how those immunization decisions will be made as that data comes in,&quot; said Dr. Baylor.  
              &lt;p&gt; 
              &lt;p&gt;There&apos;s a chance the early data will show the vaccine is ineffective at stimulating an immune response. If that&apos;s the case, the FDA might have to issue an &quot;emergency use authorization&quot; for an oil-in-water adjuvant that sparks a stronger reaction in the immune system, but causes more side effects.
              &lt;p&gt; 
              &lt;p&gt;There are currently no licensed influenza vaccines that contain an adjuvant, and Dr. Baylor said he couldn&apos;t recall a time when the FDA issued an emergency use authorization for a vaccine. 
              &lt;p&gt; 
              &lt;p&gt;Two companies, GlaxoSmithKline and Novartis, are applying for approval for vaccines that contain oil-in-water adjuvants. The NIH is also conducting a trial of an adjuvant-enhanced vaccine. 
              &lt;p&gt; 
              &lt;p&gt;The panel&apos;s consumer representative said if the FDA does issue an emergency use authorization for a adjuvanted vaccine, she would prefer as little adjuvant as possible to avoid side effects.
              &lt;p&gt; 
              &lt;p&gt;Another panelist, Theodore Eickhoff, MD, an infectious disease specialist at the University of Colorado, said adjuvanted flu vaccines have been used for a decade in Europe and have not been shown to harm vulnerable populations, such as children.
              &lt;p&gt; 
              &lt;p&gt;&quot;I don&apos;t want FDA . . . to walk away from this meeting thinking we&apos;re all scared of adjuvanted vaccines,&quot; Dr. Eickhoff said. &quot;Some of us are. I&apos;m not. I&apos;m delighted the options are there.&quot;
              &lt;p&gt; 
              &lt;p&gt;The government has already purchased a supply of 120 million adjuvant doses that it will add to its antigen supply if it there is a shortage of the vaccine, or if the standard versions are shown to be ineffective.
              &lt;p&gt; 
              &lt;p&gt;The panel did not reach consensus on whether patients should receive one or two doses. Once trial data becomes available, it will be more apparent whether doses given 21 days apart are superior to a single dose, members indicated.
              &lt;p&gt; 
              &lt;p&gt;The committee agreed that pregnant women should be immunized, but did not recommend inoculation of babies under six months old.
              &lt;p&gt; 
              &lt;p&gt;The chairman of the committee, a pediatrician, said the FDA might want to prepare for an infant vaccination program if surveillance data indicate a wider pandemic than expected. 
              &lt;p&gt; 
              &lt;p&gt;&quot;I don&apos;t think it would be a bad idea to have a game plan to immunize babies under six months in case of emergency,&quot; said John Modlin, MD, a pediatrician at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. 
              &lt;p&gt; 
              &lt;p&gt;FDA officials also told the panel that vaccine manufactures are getting only one-third as much antigen from the pandemic H1N1 strain as they normally get from the seasonal flu virus. That might mean vaccine makers won&apos;t be able to make as many doses as they planned. 
              &lt;p&gt; 
              &lt;p&gt;The CDC&apos;s Advisory Committee on Immunization Practices will meet in Atlanta next week to vote on which populations should be vaccinated first, among other issues. 
              
    </recommendedItem>
</recommendedContent>
