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.

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.

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.

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.

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.

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.

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." FDA has called off plans to close seven of its 13 labs as part of the Office of Regulatory Affairs reorganization it announced in March, Dingell and fellow Michigan Democrat Bart Stupak, Oversight and Investigation Subcommittee chairman, say in a release (¹"The Tan Sheet" March 26, 2007, p. 5). The House has passed legislation with FDA's fiscal 2008 appropriations with an amendment from Stupak that prohibits the agency from using any of the funding to pay for closing its field labs or ORA district offices....

This article is reprinted from "The Tan Sheet" – August 20, 2007

Click here to start your 30-day, risk-free trial of "The Tan Sheet" – “The Tan Sheet” is the OTC and dietary supplement industry’s leading source of business and regulatory news and analysis.

© FDC Reports 2007 - All Rights Reserved

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.

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.

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. The bill, which had not been filed or assigned a number as of Aug. 10, would also prevent FDA from closing or consolidating its 13 FDA field laboratories, Dingell says in an Aug. 3 release. "Without regular inspections and analysis there is little incentive for food producers and importers to ensure that our food supply is free from harmful and sometimes fatal contaminants," he says. The bill would grant FDA authority to issue mandatory recalls; require country of origin labeling; limit the number of ports of entry for food items; halt imports of certain products until a foreign facility can demonstrate that significant steps have been taken to rectify an identified problem; and increase civil monetary penalties for manufacturers or importers that violate the Food, Drug and Cosmetic Act. Dingell has been a frequent critic of FDA's food safety oversight and has said he would introduce legislation to bring about sweeping changes (¹"The Tan Sheet" July 9, 2007, p. 9)....

This article is reprinted from "The Tan Sheet" – August 13, 2007

Click here to start your 30-day, risk-free trial of "The Tan Sheet" – “The Tan Sheet” is the OTC and dietary supplement industry’s leading source of business and regulatory news and analysis.

© FDC Reports 2007 - All Rights Reserved