Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Susan Haigney

In their effort to help industry develop abuse-deterrent opioids, FDA has released 

Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling, Draft Guidance

 (CDER, Silver Spring, MD, January 2013). This 

 gives guidance on studies conducted to demonstrate that a given formulation has abuse-deterrent properties, how FDA will evaluate the studies, and what labeling FDA will approve. The draft guidance fulfills mandates under the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Office of National Drug Control Policy’s (ONDCP) Prescription Drug Abuse Prevention Plan. 

“The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation. This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse,” said FDA Commissioner Margaret A. Hamburg, MD, in a 

FDA will accept public comments on the draft guidance for 60 days and FDA “encourages additional scientific and clinical research that will advance the development and assessment of abuse-deterrent technologies.”  In addition, FDA will hold a public meeting to discuss feedback on the draft guidance. 

Articles

FDA has released Guidance for Industry: Abuse-Deterrent Opioids?Evaluation and Labeling, Draft Guidance

FDA Releases Guidance on Opioids

 February issue will feature a guest editorial by Aaron Davidson, a partner in the life sciences practice at Baker Botts, on social media and the pharmaceutical industry. In his editorial, Mr. Davidson points to FDA and a lack of regulatory guidance as the reasons that social media has not caught on in the pharma and bio/pharma industries. FDA’s requirement to provide consumers with FDA-approved promotional materials that contain risk information may limit a pharmaceutical company’s ability to use mediums such as Twitter and Facebook effectively.

	For the pharmaceutical industry, social media poses concerns that range from release of propriety information to regulatory constraints to patient safety. These concerns have limited the industry’s use of a potential marketing and networking tool. Other industries are using Twitter, Facebook, and other social media outlets to promote products, follow consumer trends, and connect directly with their consumers.

	Is social media being used effectively at all in the pharmaceutical industry? Are there ways social media can be positively used by industry members to share ideas, connect with industry members, or even promote products? And if there is a fear of regulatory infractions, what can or should FDA and other international regulatory agencies do to promote the use of social media?

PharmTech’s February issue will feature a guest editorial by Aaron Davidson, a partner in the life sciences practice at Baker Botts, on social media and the pharmaceutical industry.

Social Media and the Pharma Industry

 March issue will feature an update on process analytical technologies that will include a focus on validation. As part of my research for the March feature, I would like to know your answer to the following question.

	How has the FDA process validation guidance, 

Guidance for Industry: Process Validation: General Principles and Practices,

 changed validation in pharmaceutical manufacturing?

	Please send your answers to shaigney@advanstar.com or post them directly here in the comments section.

PharmTech’s March issue will feature an update on process analytical technologies that will include a focus on validation.

Process Validation’s Impact on Manufacturing

	A new year has started in the world of pharmaceutical manufacturing and technology, and 2013 looks to bring plenty of innovation. 

’s January issue highlights what the pharma industry can expect in the upcoming year.

	Look for a discussion with FDA on the changing scope of regulatory science and its effect on drug reviews, site inspections, and approvals as well as academia’s role in the future of pharmaceutical manufacturing. We will also have a look at the future of CMOs and ISPE’s view on the future of the quality laboratory.

	We would also like to know what you think the new year will bring! Please leave your comments on what your company’s goals and innovative projects are for the new year, and be sure to let us know what you would like to see us cover in the year to come!

A new year has started in the world of pharmaceutical manufacturing and technology, and 2013 looks to bring plenty of innovation.

A New Year in Pharma

 a Missouri consumer class-action suit, which claimed the company violated the Missouri Merchandising Practices Act when it promoted and sold its pain reliever Vioxx. Merck removed Vioxx from shelves in 2004 due to evidence that it increased the risk of heart attacks.  According to the Justice Department, Merck began marketing Vioxx as a treatment for rheumatoid arthritis shortly after being approved by FDA as a painkiller in May 1999. However, FDA had not approved it for the treatment of rheumatoid arthritis until 2002. The settlement is 

 for $220 million and Merck agreed to pay validated claims as well as approved attorneys’ fees, and settlement notice costs.

	Merck’s press release on the settlement didn’t mention any admission of wrongdoing. In a company press release, Bruce N. Kuhlik, Merck’s executive vice-president and general counsel, said “This agreement is in the best interest of the company and its shareholders. It reduces the uncertainty of litigation and ongoing defense costs, and helps us to remain focused on bringing forward innovative products and services for our customers.” This is one of several recent examples of off-label drug promotion. Are the millions pharma companies end up paying in lawsuit payouts worth sidestepping FDA rules?

Last week, Merck agreed to settle a Missouri consumer class-action suit, which claimed the company violated the Missouri Merchandising Practices.

Merck Settles in Missouri Class Action Lawsuit

The United States Pharmacopeial Convention (USP) has revised its current labeling standards for heparin sodium injections and heparin lock flush solutions to address safety concerns about the expression of the drugs’ strength. USP said in a 

 that a misunderstanding of the expression of total strength on multidose product labels might cause errors that could lead to serious consequences to patients. According to USP, the change in labeling will mostly impact heparin multiple-dose vials.

The new standards, which go into effect on May 1, 2013, are addressed in the labeling sections of the Heparin Sodium Injection and Heparin Lock Flush Solution monographs in the 

United States Pharmacopeia/National Formulary

). The monographs are being revised to comply with 

 General Chapter <1> Injections, which requires “that the label reflect strength per total volume as the primary expression of strength followed in close proximity by strength per mL.”

The revision addresses a 2010 letter from FDA to USP expressing concern that healthcare practitioners often misunderstood product labels with strength statements written as “mg per mL” as total drug content statements, which could lead to improper patient dosing. USP’s Safe Medication Use Expert Committee reviewed FDA’s concerns.

In the press release, Roger L. Williams, USP’s CEO, said, “USP is committed to developing standards that help to advance public health. It is our goal to ensure that USP standards aid practitioners in their delivery of quality care to patients. Particularly in light of the public health emergency involving adulterated heparin in 2008, USP and FDA are continuing to work closely together to help ensure that heparin delivery is as safe and accurate as possible.”

USP will post the official monographs in the “Official Text” section on its 

USP revises labeling requirements for Heparin.