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    <recommendedItem id="20100101_19_343"
                     title="U.S. Marshals Seize Unapproved Ozone Generators"
                     score="0.011"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265734302311"
                     
      &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=1265734302311"
                     
      &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_1482"
                     title="Democrats Push Medical Device Liability Bill"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Washington-Watch/Washington-Watch/tb/14178?impressionId=1265734302311"
                     
       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_2552"
                     title="FDA Device Chief Quits as Ethics Probe Targets CDER Director"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Washington-Watch/Washington-Watch/tb/15520?impressionId=1265734302311"
                     
      Daniel G. Schultz, MD, director of FDA&apos;s Center for Devices and Radiological Health, has resigned by &quot;mutual agreement&quot; with Commissioner Margaret Hamburg, MD.
&lt;p&gt;The announcement came just as it was also disclosed that Janet Woodcock, MD, longtime head of the agency&apos;s Center for Drug Evaluation and Research, is under investigation after a manufacturer accused her of having inappropriate professional ties to officials of a rival company making the same drug.&lt;/p&gt;
&lt;p&gt;Schultz has headed the CDRH since 2004 and has spent a total of 15 years in the unit, which regulates medical devices and other hardware, in vitro diagnostics, and radiation-emitting products (including nonmedical devices such as microwave ovens).&lt;/p&gt;
&lt;p&gt;His resignation follows accusations from inside and outside the FDA that the division was too cozy with the device industry. Sen. Charles Grassley (R-Iowa) has probed allegations that devices were approved despite unfavorable reviews by the center&apos;s professional staff.&lt;/p&gt;
&lt;p&gt;Last year, a group of CDRH staff reviewers sent a letter to the House Energy and Commerce Committee complaining that they had been pressured by their superiors to recommend device approvals against the evidence. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/11858&quot; mce_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;Schultz said his resignation came after a meeting with his new boss, Hamburg, &quot;by mutual agreement.&quot; An FDA spokesman later said the decision did not stem from any specific issue.&lt;/p&gt;
&lt;p&gt;FDA Associate Commissioner Jeff Shuren was picked to run the CDRH on an interim basis.&lt;/p&gt;
&lt;p&gt;Meanwhile, Woodcock stands accused of having excessively close contacts with drug manufacturer Momenta Pharmaceuticals, which is seeking approval for a generic version of enoxaparin, the low molecular weight heparin drug, now sold under the brand name Lovenox.&lt;/p&gt;
&lt;p&gt;Woodcock has headed CDER since 1994, except for a two-year stint as deputy commissioner during the George W. Bush presidency.&lt;/p&gt;
&lt;p&gt;An ethics complaint was filed by a rival firm, Amphastar Pharmaceuticals, which also has an application for generic enoxaparin under CDER&apos;s review.&lt;/p&gt;
&lt;p&gt;Neither product has been approved yet. Last year, the agency said both companies needed to submit additional data demonstrating that the drugs were not immunogenic.&lt;/p&gt;
&lt;p&gt;Amphastar, which filed its enoxaparin application two years before Momenta, charged that the other company had too much influence with the CDER as a result of collaboration with Woodcock on two journal articles. One of them, dealing with last winter&apos;s heparin contamination scandal, was published in the &lt;em&gt;New England Journal of Medicine &lt;/em&gt;in June.&lt;/p&gt;
&lt;p&gt;Ten Momenta employees, as well as company co-founder Ram Sasisekharan, PhD, of the Massachusetts Institute of Technology, were authors of the &lt;em&gt;NEJM&lt;/em&gt; article along with Woodcock and several FDA staff scientists, as well as academic researchers.&lt;/p&gt;
&lt;p&gt;Woodcock and Sasisekharan exchanged e-mails and had other contacts, including attendance at a 2007 medical meeting in Thailand, according to Amphastar&apos;s complaint.&lt;/p&gt;
&lt;p&gt;The Inspector General&apos;s Office at the Department of Health and Human Services is now investigating the complaint, according to an FDA spokesman, who said Woodcock did not plan to recuse herself from consideration of the firms&apos; enoxaparin applications.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20090101_19_2628"
                     title="FDA Goes Paperless for Adverse Event Reporting"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Washington-Watch/Washington-Watch/tb/15617?impressionId=1265734302311"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has proposed a mandatory switch to digital postmarket reporting of adverse effects of drug and medical devices to streamline and hasten its investigations.&lt;/p&gt;
&lt;p&gt;The agency&apos;s plans would not change what is reported but rather how it is reported, leading to a more rapid analysis of potential safety hazards. Currently, most reports are filed on paper and must be entered manually into a database for further analysis.&lt;/p&gt;
&lt;p&gt;A switch to digital submission would save money and improve communication with the FDA and other regulators, said Gerald J. Dal Pan, MD, director of the Center for Drug Evaluation and Research&apos;s Office of Surveillance and Epidemiology, in a prepared statement.&lt;/p&gt;
&lt;p&gt;The new rules would not affect reports for: &lt;ul&gt; &lt;li&gt;Voluntary adverse event reporting&lt;/li&gt; &lt;li&gt;Investigational drug applications&lt;/li&gt; &lt;li&gt;Annual reports on approved drugs&lt;/li&gt; &lt;li&gt;Biologic product deviation&lt;/li&gt; &lt;li&gt;Complications of blood transfusion and collection confirmed to be fatal&lt;/li&gt; &lt;li&gt;Certain reports on human cell and tissue-based products&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;For medical devices, voluntary reporting of safety issues would also be unaffected.&lt;/p&gt;
&lt;p&gt;The electronic medical device reporting system offers two methods of report submission  --  a free program called &quot;eSub&quot; for manufacturers submitting limited numbers of reports, and a batch submission Individual Case Safety Report when filing large numbers of reports.&lt;/p&gt;
&lt;p&gt;The agency has already tested out electronic adverse event reports through a pilot program launched in 2000.&lt;/p&gt;
&lt;p&gt;Manufacturers looking to submit reports need to obtain an electronic certificate to use the FDA Electronic Submissions Gateway.&lt;/p&gt;

    </recommendedItem>
</recommendedContent>
