Angie Drakulich was editorial director of Pharmaceutical Technology.

Angie Drakulich

-President-elect Barack Obama officially nominated former Senator Tom Daschle as Secretary of Health and Human Services and named him the Director of a new White House Office on Health Care Reform late last week. Dr. Jeanne Lambrew, of the University of Texas, will serve as Deputy Director of the White House Office of Health Reform, according to a news release from the Office of the President-elect.

"The time has come … to modernize our healthcare system for the 21st century; to reduce costs for families and businesses; and to finally provide affordable, accessible health care for every American,” said Obama in the release.

Daschle has the support of the Pharmaceutical Research and Manufacturers of America (PhRMA). He “has what it takes to do the job: smarts, toughness and a strong understanding of the healthcare challenges that face our nation in these tough economic times,” said PhRMA Chief Executive Officer Billy Tauzin in a Nov. 19 

The official nomination for the next commissioner of the US Food and Drug Administration is still up in the air. Several candidates’ names have been mentioned (see related 

Articles

President-elect Barack Obama officially nominated former Senator Tom Daschle as Secretary of Health and Human Services and named him the Director of a new White House Office on Health Care Reform late last week.

Obama Officially Nominates Daschle as HHS Head

The Federal Trade Commission (FTC) is seeking public comment on proposed revisions to its 

Guides Concerning the Use of Endorsements and Testimonials in Advertising

 Part 255, were issued in 1972 and are designed to assist businesses, including the pharmaceutical industry, and others conform their endorsement and testimonial advertising practices to the requirements of Section 5 of the FTC Act, according to the Commission’s Nov. 28 

In January 2007, as part of its ongoing regulatory review process, FTC published a 

 notice seeking comment on the overall costs, benefits, and regulatory and economic impact of the guides. FTC received 22 comments and is now proposing various amendments.

The current guides state that endorsements must reflect the honest opinions, findings, beliefs, or experience of the endorser and may not contain any representations that would be deceptive, or could not be substantiated, if made directly by the advertiser. One of the primary changes is to apply the guides’ practices to televised interviews. For example, if a celebrity spokesperson endorses by name a product during a TV interview, it must be made clear that the celebrity is a paid spokesperson for the company or product.

Endorsements about a product’s efficacy must also be based on “adequate substantiation,” according to the new guides’ proposals. Endorsers presented as “experts” must also have qualifications that give the endorser the expertise he or she is represented as presenting. In addition, endorsers of products who are represented as 

 users of the products they are representing must in fact be users of the product-and once it’s clear that an endorser has stopped being a 

 user of the product, the advertisements that represent the endorser as such can no longer be run. 

Read the full FTC proposal, including explanations of the 22 comments received since 2007, in the 

  Comments on the revised propsoals are due on Jan. 30, 2009 and can be submitted electronically 

The Federal Trade Commission (FTC) is seeking public comment on proposed revisions to its Guides Concerning the Use of Endorsements and Testimonials in Advertising.

FTC Seeks to Revise Use of Ad-Based Endorsements and Testimonials

The US Food and Drug Administration issued a draft guidance, 

Contents of a Complete Submission for the Evaluation of Proprietary Names

, on Nov. 24, 2008. FDA uses information from these submissions to assess the safety aspects of a proposed proprietary name in an effort to reduce medication errors as well as to ensure compliance with labeling and promotion requirements. 

The Prescription Drug User Fee Act of 2007 (PDFUA IV) calls for FDA to use user fees to “reduce medication errors related to look-alike and sound-alike proprietary names, unclear label abbreviations, acronyms, dose designations, and error-prone label and packaging designs,” according to the draft guidance. 

Under the draft guidance, an FDA evaluation of a proprietary name review package will not begin until the submission is complete. A complete package will include the drug sponsor’s: proposed first choice proprietary name; application number; contact information; identification of the type of submission; and a list of contents in the submission such as labeling information, dosage form, route of administration, and so forth.

The draft guidance applies to both nonprescription and prescription drug products, including biologics, that are the subject of a new drug application, abbreviated new drug application, biologics license application, or investigational new drug application.

Comments on the draft guidance are due within 60 days to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

The US Food and Drug Administration issued a draft guidance, Contents of a Complete Submission for the Evaluation of Proprietary Names, on Nov. 24, 2008.

Draft Guidance Details Complete Proprietary Names Package

-The US Food and Drug Administration issued a draft guidance on Nov. 18, 2008, titled 

Process Validation: General Principles and Practices

 for comment. The guidance is meant to serve as a revision to the 1987 

Guideline on General Principles of Process Validation

The new draft guidance, based in part on the agency’s 

Pharmaceutical CGMPs for the 21st Century 

initiative, promotes a ‘‘life cycle’’ approach that focuses on scientifically sound design practices, robust qualification, and process verification, according to the Nov. 18, 2008, 

. The life cycle approach breaks down process validation into three stages: process design, process qualification, and continued process verification. The draft guidance is also aligned with International Conference on Harmonization quality guidance documents such as Q8: 

The guidance will apply to process validation of human and animal drug and biological products, including active pharmaceutical ingredients. 

Comments are due Jan. 20, 2009, and can be sent in writing to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Ln., Rm. 1061, Rockville, MD 20852 or  submitted electronically at www.regulations.gov. 

The US Food and Drug issued a draft guidance on Tuesday, Nov. 18, titled Process Validation: General Principles and Practices for comment. The guidance is meant to serve as a revision to the 1987 Guideline on General Principles of Process Validation.

New Draft Guidance on Process Validation

-The US Food and Drug Administration issued a direct final rule last week to adjust for inflation the maximum civil money penalty amounts for various civil money penalty authorities under the agency’s jurisdiction. The rule is meant to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended, which calls for civil money penalties to be adjusted every four years. The rule does not adjust the civil money provisions enacted by the FDA Amendments Act of 2007 (FDAAA), according to the Nov. 12 

FCPIAA defines a civil monetary penalty as ‘‘any penalty, fine, or other sanction that-(A)(i) is for a specific monetary amount as provided by Federal law; or (ii) has a maximum amount provided for by Federal law; and (B) is assessed or enforced by an agency pursuant to Federal law; and (C) is assessed or enforced pursuant to an administrative proceeding or a civil action in the Federal Courts (28 USC 2461 note, section 3(2)),” according to 

The new direct final rule revises the current list of statutory monetary penalties in 21 

 Part 17 to include new penalties prescribed by the Federal Food, Drug, and Cosmetic Act, as amended by FDAAA in 2007. FDAAA penalties now account for inflation between June 2004 (the year of the last adjustment) and June 2007.

View a table showing the increased maximum penalties 

. 
  
The rule takes effect Mar. 27, 2009. Comments on the rule are due Jan. 26, 2009 and can be sent in writing to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Ln., Rm. 1061, Rockville, MD 20852 or  submitted electronically on 

The US Food and Drug Administration issued a direct final rule last week to adjust for inflation the maximum civil money penalty amounts for various civil money penalty authorities under the agency's jurisdiction.

Civil Money Penalties Increased

)-Rep. John Dingell (D-MI) plans to introduce the Food and Drug Globalization Act discussion draft as a bill early next year. Chairman of the House Energy and Commerce Committee, Dingell has been active in this issue for some time, introducing the discussion draft last spring and a 

 in July. Among other things, the Act would enhance FDA's authority and increase funds for its inspections and compliance programs. 

“We need to ensure the safety of our food and drug supply in a global economy,” he said in a statement issued to the Democratic caucus on Nov. 6, 2008. “Already, I’ve released draft legislation to strengthen and adequately fund FDA, thereby improving the safety of food, drugs, medical devices, and cosmetics. Work on the Food and Drug Administration Globalization Act continues. I will introduce this bill early next year and intend to move it through the Committee with the utmost speed.”

Dingell’s statement was part of a longer letter to the Democratic caucus that focused on his desire to serve another term as chairman of the House Energy and Commerce Committee. Rep. Henry Waxman (D-CA) is challenging the chairmanship, which will be decided when the 111th Congressional session begins in January 2009.

Dingell also has been active in the area of drug import safety, sponsoring H.R. 3610, the Food and Drug Import Safety Act of 2007. This Act would create a user fee on imported drug and food shipments. Funds generated by the fee would be used to hire additional personnel to perform inspections worldwide to increase the analysis of drug and food imports. Funds would also be used to test import samples and research new testing techniques. See PharmTech’s 

Rep. John Dingell (D-MI) plans to introduce the Food and Drug Globalization Act discussion draft as a bill early next year.