FDALegislativeWatch

Overview of the Week's Top FDA Legislative Developments: August 30, 2007

  (Please Note: this section provides complimentary previews of all articles, links to this week's featured articles and links to other articles that require subscription or paid access)

Food Safety

• Featured Article: ORA Lab Closings Cancelled But Reorganization Not Off The Table - Staffers  FDA's head of regulatory affairs' Aug. 17 message to staff about cancelling plans to close seven field labs did not mark the end of the agency's ORA reorganization work, staff members say. (August 27, 2007, "The Tan Sheet") - Complimentary access.
• Dingell Questions Ingredient Testing Exemption Rule, Cites Supply Climate House Energy and Commerce Committee Chairman John Dingell is questioning allowing exemptions from 100 percent identity testing requirements for dietary supplement ingredients in light of mounting food safety issues. (August 27, 2007, "The Tan Sheet") - Subscription required, Click here for a FREE trial.

Patent Reform

• Featured Article: New Patent Rules May Hurt Biotech Industry; Limits Set On Certain Filings  The U.S. Patent and Trademark Office is implementing new rules on patent filings that will make it tougher for biotechnology companies to protect their inventions. (August 27, 2007, "The Pink Sheet") - Complimentary access.

Medical Devices

• Medical Device Reports To FDA Rose 77% In 2006  The number of adverse events reported to FDA under the Medical Device Reporting (MDR) program rose last year to an all-time high, and agency staffers predict the trend will continue through 2007. (August 27, "The Gray Sheet") - Requires subscription or paid access.
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DTC Advertising

• Rx TV Ads To Get FDA Study On How Visual Cues May Distract From Audio Risks  FDA  Data collection in an FDA study of how the audio, visual and textual components of a television ad affect a viewer's intake of information and perception of a drug's risks and benefits is expected to begin in May 2008. . (August 27, 2007, "The Pink Sheet") Requires subscription or paid access. Click here for a FREE trial.

Food Safety

• Featured Article: ORA Lab Closings Cancelled But Reorganization Not Off The Table - Staffers  FDA's head of regulatory affairs' Aug. 17 message to staff about cancelling plans to close seven field labs did not mark the end of the agency's ORA reorganization work, staff members say. (August 27, 2007, "The Tan Sheet") - Complimentary access.
• Dingell Questions Ingredient Testing Exemption Rule, Cites Supply Climate House Energy and Commerce Committee Chairman John Dingell is questioning allowing exemptions from 100 percent identity testing requirements for dietary supplement ingredients in light of mounting food safety issues. (August 27, 2007, "The Tan Sheet") - Subscription required, Click here for a FREE trial.

Patent Reform

• Featured Article: New Patent Rules May Hurt Biotech Industry; Limits Set On Certain Filings  The U.S. Patent and Trademark Office is implementing new rules on patent filings that will make it tougher for biotechnology companies to protect their inventions. (August 27, 2007, "The Pink Sheet") - Complimentary access.

Medical Devices

• Medical Device Reports To FDA Rose 77% In 2006  The number of adverse events reported to FDA under the Medical Device Reporting (MDR) program rose last year to an all-time high, and agency staffers predict the trend will continue through 2007. (August 27, "The Gray Sheet") - Requires subscription or paid access.
  Click here for a FREE trial.

DTC Advertising

• Rx TV Ads To Get FDA Study On How Visual Cues May Distract From Audio Risks  FDA  Data collection in an FDA study of how the audio, visual and textual components of a television ad affect a viewer's intake of information and perception of a drug's risks and benefits is expected to begin in May 2008. . (August 27, 2007, "The Pink Sheet") Requires subscription or paid access. Click here for a FREE trial.

Food Safety

• Featured Article: ORA Lab Closings Cancelled But Reorganization Not Off The Table - Staffers  FDA's head of regulatory affairs' Aug. 17 message to staff about cancelling plans to close seven field labs did not mark the end of the agency's ORA reorganization work, staff members say. (August 27, 2007, "The Tan Sheet") - Complimentary access.
• Dingell Questions Ingredient Testing Exemption Rule, Cites Supply Climate House Energy and Commerce Committee Chairman John Dingell is questioning allowing exemptions from 100 percent identity testing requirements for dietary supplement ingredients in light of mounting food safety issues. (August 27, 2007, "The Tan Sheet") - Subscription required, Click here for a FREE trial.

Patent Reform

• Featured Article: New Patent Rules May Hurt Biotech Industry; Limits Set On Certain Filings  The U.S. Patent and Trademark Office is implementing new rules on patent filings that will make it tougher for biotechnology companies to protect their inventions. (August 27, 2007, "The Pink Sheet") - Complimentary access.

Medical Devices

• Medical Device Reports To FDA Rose 77% In 2006  The number of adverse events reported to FDA under the Medical Device Reporting (MDR) program rose last year to an all-time high, and agency staffers predict the trend will continue through 2007. (August 27, "The Gray Sheet") - Requires subscription or paid access.
  Click here for a FREE trial.

DTC Advertising

• Rx TV Ads To Get FDA Study On How Visual Cues May Distract From Audio Risks  FDA  Data collection in an FDA study of how the audio, visual and textual components of a television ad affect a viewer's intake of information and perception of a drug's risks and benefits is expected to begin in May 2008. . (August 27, 2007, "The Pink Sheet") Requires subscription or paid access. Click here for a FREE trial.

Overview of the Week's Top FDA Legislative Developments: August 21, 2007

  (Please Note: this section provides complimentary previews of all articles, links to this week's featured articles and links to other articles that require subscription or paid access)

Rx Drug Safety

• Featured Article: Avandia And Actos Add "Black Boxes" For Heart Failure  As an interim step in its ongoing review of thiazolidinedione cardiac safety, FDA has called for revised class labeling for the TZDs featuring strengthened warnings about the incidence of heart failure and contraindications for patients with existing heart failure. (August 20, 2007, "The Pink Sheet") - Complimentary access.
• U.S. Delegation Visits China To Jump Start Development Of Safety MOAs  Two Memoranda of Agreement will focus on drug and medical device safety, and food and feed safety.  (August 15, 2007, "The Pink Sheet" DAILY) Requires subscription or paid access. Click here for a FREE trial.

Food Safety

• Featured Article: FDA Labs Stay Open  House Energy and Commerce Chairman John Dingell says an Aug. 17 decision by FDA to not proceed with reorganization plans that include closing seven of its field labs will maintain an "essential part of protecting consumers and ensuring the safety of our nation's food and drug supply." (August 20, 2007, "The Tan Sheet") - Complimentary access.
• China Commits To Tightening Food Safety Supervision As MOA Talks Begin  A spokesman at the Chinese embassy in Washington says China will intensify its food safety supervision as U.S. and Chinese officials in Beijing begin work on a memorandum of agreement on food and feed safety. (August 20, 2007, "The Tan Sheet") Requires subscription or paid access. Click here for a FREE trial.

Medical Devices

• Featured Article: Lawmakers Probe FDA Over Handling Of Cordis Warning Letter  The House Energy and Commerce Committee sent letters to FDA and Johnson & Johnson Aug. 13 requesting documents as part of an inquiry into FDA's Office of Regulatory Affairs. (August 20, 2007, "The Gray Sheet") - Complimentary access.
• When In Doubt: Do Ask, Do Tell FDA About Possible Recalls, Officials Say  Device companies fretting over whether to tell FDA about every product glitch or packaging error that might result in a market withdrawal or recall should phone their FDA district recall officers and ask about it, CDRH Senior Recall Coordinator Michael Verdi said Aug. 14 at an industry conference. (August 20, 2007, "The Gray Sheet") - Requires subscription or paid access. Click here for a FREE trial.

Patent Reform

• Featured Article: PTO Proposed Rule Could Force Drug Firms To File More Patent Applications  Biotech and pharmaceutical companies may have to spend more time and money to patent their inventions under a new regulation proposed by the Patent and Trademark Office. (August 20, 2007, "The Pink Sheet") - Complimentary access.

DTC Advertising

• FDA Ad Letters Focus On Superiority Claims; Oversight Critiqued On Several Fronts  FDA appears to have shifted the focus of its advertising oversight and is concentrating on superiority claims as opposed to safety issues; the agency also seems to have relaxed the tone of its enforcement, relying more on "untitled" letters than it has in the past. (August 20, 2007, "The Pink Sheet") Requires subscription or paid access. Click here for a FREE trial.

Overview of the Week's Top Legislative Developments: August 14, 2007

   (Please Note: this section provides complimentary previews of all articles, links to this week's featured articles and links to other articles that require subscription or paid access)

Rx Drug Safety

• Featured Article: Inspection Of Rx Imports Would Climb Under Bill Setting $300 Mil. In User Fees  Drug import fees totaling $300 million each in fiscal years 2008 through 2012 would be authorized by a food and drug import safety bill being developed by House Energy and Commerce Committee Chairman John Dingell, D-Mich. (August 13, 2007, "The Pink Sheet") - Complimentary access.
• Featured Article: Antidepressant Black Boxes Updated Class labeling for antidepressants is updated Aug. 2 to include warnings about increased risks of suicidality in young adults ages 18 to 24. The new language, which FDA proposed in May, states that risk was not seen in adults older than 24 and that the risk decreased for adults ages 65 and older (¹"The Pink Sheet" May 7, 2007, p. 32). (August 13, 2007, "The Pink Sheet") - Complimentary access.
• FDA To Complete Prilosec, Nexium Safety Review In November, CDER Says
  FDA is continuing to investigate safety data on AstraZeneca's proton pump inhibitors Prilosec and Nexium (omeprazole and esomeprazole, respecttively), but announced a preliminary conclusion the drugs do not present an increased cardiovascular risk. (August 13, 2007, "The Tan Sheet") Requires subscription or paid access. Click here for a FREE trial.

Food Safety

• Featured Article: Dingell Food Safety Bill  House Energy and Commerce Chairman John Dingell's, D-Mich., draft legislation on food safety would require FDA to collect user fees on food imported into the U.S., with the revenue used to support import inspections, lab testing on import samples and research on testing techniques for intentionally adulterated food imports. (August 13, 2007, "The Tan Sheet") - Complimentary access.
• Wisconsin Delegation Proposes "Country Of Harvest" On Raw Ginseng Labels
  Members of the congressional delegation from Wisconsin, where about 95 percent of U.S. ginseng is cultivated, have proposed amending agricultural manufacturing regulations to require labels for raw ginseng roots indicate the country of harvest. (August 13, 2007, "The Tan Sheet") Requires subscription or paid access. Click here for a FREE trial.

Medical Devices

• Featured Article: Stakeholders Unfazed By Call For Study On Device-Related Infections  The section of the House FDA user fee bill (H.R. 2900) which calls for a study on hospital-acquired infections attributable to new and reused medical devices has not raised any hackles so far. (August 13, 2007, "The Gray Sheet") - Complimentary access.

Overview of the Week's Top FDA Legislative Developments: August 6, 2007

   (Please Note: this section provides complimentary previews of all articles, links to this week's featured articles and links to other articles that require subscription or paid access)

Rx Drug Safety

• Drug Safety Issues Deserve Double Standard, Nissen Tells "The Pink Sheet"  The Chairman of Cleveland Clinic's Department of Cardiovascular Medicine Steven Nissen is the co-author of the meta-analysis that drew attention to the potential cardiovascular risk associated with GlaxoSmithKline's type 2 diabetes drug Avandia (rosiglitazone) earlier this year. A former chair of FDA's Cardio-Renal Drugs panel, Nissen appeared at the July 30 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee as a non-voting consultant, although without the proverbial seat at the table. Nissen provided his reaction to the committee debate in an interview with "The Pink Sheet." (August 6, 2007, "The Pink Sheet") - Complimentary access.

FDA Revitalization Act

• Featured Article: FDA Receives Assurances That PDUFA Remains Priority on Capitol Hill  As Congress prepared to adjourn for summer recess without reauthorizing the Prescription Drug... (August 6, 2007, "The Pink Sheet") - Complimentary access.

• FDA Does Not Intimidate, Promotes "Diversity Of Opinion"  Von Eschenbach Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., contends FDA executives' actions "do not address a culture at FDA that permits senior level political appointees to intimidate civil servants who speak plainly to Congress about what is happening at FDA," a spokesman said in an e-mail. (August 6, 2007, "The Tan Sheet") Requires subscription or paid access. Click here for a FREE trial.

• Von Eschenbach Holds FDA RIFs At Bay With Reserve Fund, But Staff Stability Remains A Concern   PDUFA carry over funds enable FDA to avoid reduction-in-force process.... (August 3, 2007, "The Pink Sheet" DAILY) Requires subscription or paid access. Click here for a FREE trial.

• Featured Article: FDA Reform Bill May Be Delayed Until September; FDA Holds Tight On Staffing Issues  Reauthorization of prescription drug user fees will go down to the wire as... (July 31, 2007, "The Pink Sheet" DAILY) - Complimentary access.

Food Safety

• FDA Reconsiders ORA Reorganization As Questions From Congress Continue  FDA's Aug. 1 decision to temporarily suspend its plans to close seven of its 13... (August 6, 2007, "The Tan Sheet") Requires subscription or paid access. Click here for a FREE trial.
• Stirring Up Food Safety Discussions On HHS Officials' Agenda In Beijing  Department of Health and Human Services officials are consulting with Chinese... (August 6, 2007, "The Tan Sheet") Requires subscription or paid access. Click here for a FREE trial.
• Hill Scrutiny Of FDA Staff Dissent Spills Over Into Food Safety   Members of Congress accuse FDA officials of attempting to intimidate FDA... (July 30, 2007, "The Pink Sheet") Requires subscription or paid access. Click here for a FREE trial.

Overview of the Week's Top FDA Legislative Developments: July 30, 2007

    (Please Note: this section provides complimentary previews of all articles, links to this week's featured articles and links to other articles that require subscription or paid access)

FDA Revitalization Act

• Featured Article: FDA's Implementing Visionary: A Conversation With COO John Dyer   FDA's efforts to help usher in the bioinformatics era are personified by Deputy...  (July 30, 2007, "The Pink Sheet") - Complimentary access.
• FDA Creates Position To Respond To Congress's Request For Information   FDA has created the position of senior legislative analyst for oversight in... (July 30, 2007, "The Tan Sheet") - Requires subscription or paid access.

Food Safety

• Featured Article: Congress Slams FDA Executives' Response To Staff's Food Safety Testimony   Members of Congress are accusing FDA senior officials of attempting to...  (July 30, 2007, "The Tan Sheet") - Complimentary access.
• Hill Scrutiny Of FDA Staff Dissent Spills Over Into Food Safety   Members of Congress accuse FDA officials of attempting to intimidate FDA... (July 30, 2007 "The Pink Sheet") - Requires subscription or paid access.
• Blame China? Experts Advise Congress, Industry Take A Wider View   The global scope of food safety is becoming apparent, and recent problems with... (July 30, 2007 "The Tan Sheet") - Requires subscription or paid access.
• Drug Firms Model Ensuring Import Safety; China's Inconsistencies Worry FDA   Firms using Chinese imports to make dietary supplements and other products can... (July 30, 2007 "The Tan Sheet") - Requires subscription or paid access.

Medical Devices

Featured Article: FDA User Fee Reauthorization Bill Cleared For House Floor Action   A medical device user fee reauthorization bill was approved June 21 by the House... (July 23, 2007 "The Gray Sheet") - Complimentary access.

Rx Drug Safety

• Avandia Advisory Cmte. Could Be Observational Data's Coming Out Party   The recommendations from FDA's joint advisory committee review of a signal of... (July 30, 2007 "The Pink Sheet") - Requires subscription or paid access.
• Advisory Cmte. Conflict of Interest Waivers Common; Avandia Is High Water Mark   As currently convened, the majority of FDA advisory committee meetings on drugs... (July 30, 2007, Exclusive interview with "The Pink Sheet") - Requires subscription or paid access.

Patent Reform

Patent Reform Bill In House Limits "Inequitable Conduct" Defense   Amended patent reform legislation that cleared the House Judiciary Committee... (July 30, 2007 "The Pink Sheet") - Requires subscription or paid access.