Senate Bill 3978: Home health agencies c

Senate Bill 3978: Home health agencies can assign 1st assessment of Medicare patients needing rehab to a skilled service.

This group’s blog lists the alleged cam

This group’s blog lists the alleged campaign contributions made for or against the Food Safety Bill S 510:

Senate to Vote on Food Safety Bill Tonight

The Senate will vote on  S. 510, its final version of the FDA Food Safety and Modernization Act, in an evening vote beginning at 6:30 PM EST tonight.  The  House passed its version with a large margin of supporters some time ago, so it seems safe to presume some form of  expanded federal legislation on food safety is well on the way to becoming final.    The bill’s sponsor in the Senate is Richard Durbin (R – IL), who leads a bipartisan roster of 20 co-sponsors.

Open Congress summarized some provisions of the bill, but tonight’s vote includes a couple of potentially significant amendments that aren’t that closely linked to the issue of food safety.  Take for example the two competing amendments from Republicans and Democrats that would repeal the 1099 reporting requirement previously passed in the healthcare reform bill, which has all small business owners issuing IRS-1099 forms to any vendor paid $600 more in the tax year.   The original reason for this reporting requirement was probably to help the IRS track taxable income to vendors and service providers, but it could greatly increase the reporting burden and expenses for small businesses.    The food bill also includes an amendment introduced by Senator Tom Coburn (R-OK), which formalizes the self-imposed Republican ban on earmarks. 

Provisions of the Food Safety Bill will allow:

  • FDA to order a recall if a food facility does not initiate a voluntary recall
  • New standards for produce safety during production and harvesting
  • Fees (or fines, depending on your perspective) for recalls or government reinspection of facilities
  • Regulation of sanitary food transport
  • Development of new school guidelines for managing food allergens
  • Implementation of a National Agricultural and Food Defense Strategy

Local Food Exemption:  An earlier Senate compromise exempts farmers who make less than $500,000 per year and sell directly to consumers, restaurants and groceries within a 275-mile radius of their farms from some of the bill’s requirements, such as the development of  comprehensive food safety hazard analyis and critical controls (HACCP) plan.

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Food safety bill: includes amendments no

Food safety bill: includes amendments not related to food, e.g tax reporting and earmarks. See next post.

FDA food safety bill goes to final Senat

FDA food safety bill goes to final Senate vote @ 6:30 pm ET. More to follow on what’s included.

NIH Solicits Collaborative Research Proposals for Rare Diseases; Orphan Drug Workshop Update

On Tuesday, November 2, the National Institutes of Health Center for Translational Research announced its first solicitation for collaborative research projects by NIH’s new Therapeutics for Rare and Neglected Diseases (TRND) program.  Entities interested in partnering with NIH to develop clinical candidates in this category must submit initial applications by December 6, 2010.

About two weeks ago, the FDA and NIH also co-sponsored their first workshop on Accelerating Therapies for Rare Diseases, which was aimed at supporting industry efforts to develop orphan drugs.  (Even though there is no official categorization of “orphan devices,” the process applies to these as well.)  I attended this innovative partnership meeting, which included detailed presentations and discussions with agency officials about IND requirements, clinical trial design, endpoints and standards, and use of biomarkers and surrogates for orphan drugs; as well as how applications will be evaluated, and how to communicate with FDA.

 The meeting also included a presentation on the venture community’s perspective on funding orphan drug development.  Currently, there is also a federal Orphan Grants Program which provides some limited support to researchers involved in orphan drug development, up to $200,000 per year for Phase 1 and up to $400,000 per year in phases 2 and 3.

 Accelerated orphan drug (and device) approval is available for previously marketed therapies with a newly determined orphan indication, or for an orphan drug which may also have potential therapeutic benefit in non-orphan indications. An orphan drug designation is not required for orphan drug grant funding, but there should be enough data to support the research hypothesis.

The application for collaborative research projects may be found here:

 Information on the Orphan Drug Grants Program is here:

 Current grant-funded orphan drug and device research is listed here: tp://

 For questions about the regulatory process in this area or related intellectual property issues, please feel free to contact me.


Deanna L. Baxam

Baxam Law Group, LLC

Law For Today’s Business SM

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Duluth, GA 30097

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Facebook: Baxam Law Group

Twitter: innovationlawyr



NIH solicited proposals for research on

NIH solicited proposals for research on therapies for rare/neglected diseases today; applications due 12/6/10.

USDA adds consumer representative to Nat

USDA adds consumer representative to Natl Committee on Microbiological Criteria for Foods; 12 more appointees in 2011.

Read a summary of the new 21st Century C

Read a summary of the new 21st Century Communications and Video Accessibility Act here:

Forest Laboratories Signs on the Dotted Line… with Feds

More than 6 years of pre-penalty discussions between Forest Laboratories (“Forest”) and the U.S. Attorney’s Office for the District of Massachusetts culminated September 15  in an agreement that settles criminal and civil investigations by the government into the company’s activities.  Forest agreed to plead guilty to a single felony charge of misrepresentations to FDA inspectors during a 2003 plant visit, and two misdemeanor violations of the Food, Drug and Cosmetic Act.  The first misdemeanor charge was for distributing Levothroid® after the FDA told the company an NDA would have to be filed for the drug; and the second related to off-label promotion of Celexa® for treating pediatric patients.  The fines for these charges cost Forest $150 million, and the company also forfeited another $14 million in revenues.

On the civil side, Forest also settled claims under the False Claims Act and several whistleblower (qui tam) claims relating to distribution of Levothroid® and several years of off-label promotion of Celexa® and Lexapro® for pediatric uses.  The off-label promotion in this case related to an earlier formulation of Lexapro®; Forest later requested and received approval to promote a later formulation for pediatric use.  The total payout under these civil claims, including to the feds and state Medicaid programs, was $149 million.

As a commitment to future good behavior, the government also required that Forest operate under a Corporate Integrity Agreement for five years.  Nowadays, these agreements not only call for a compliance program to be put in place, but the government also wants key senior managers, not just the CEO, to monitor and oversee activities within their scope of responsibility, and to certify they have done what is required every year.  These leaders include the heads of Marketing, R&D and Human Resources, to name a few.   The Board of Directors is also required to retain an independent Compliance Expert to review and report on the effectiveness of the Compliance Program annually.

Interestingly, news that this drawn-out investigation has come to a point of resolution seems to have helped the company’s stock performance today.  Forest closed up 2.02% from yesterday’s trading at a respectable $31.27 per share.  This might have been helped by the news that the fines were well within the reserves the company had set aside to cover the financial damage from the legal proceedings.

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