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

Susan Haigney

 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?

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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.

USP Changes Heparin Labeling Requirement

	FDA has pushed back goals in relation to the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Act (MDUFA) as a result of the closing of agency offices during Hurricane Sandy. FDA says it will assess the goals that were due October 31 and extend them as needed. The extensions will be no more than the number of business days the agency was closed.

 that it does not anticipate the need to extend goals for all applications under review and it anticipates that many applications will not require an extension. Certain applications sent that would have been received during the agency’s closure may “present issues regarding calculation of applicable review or regulatory clocks.” FDA asks that sponsors contact the review division or office responsible regarding submissions filed on October 29th or 30th.

FDA has pushed back goals in relation to the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), and Medical Device User Fee Act (MDUFA) as a result of the closing of agency offices during Hurricane Sandy.

FDA Assesses Goals due to Hurricane Sandy

	The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy. Eli Lilly Chairman, President and CEO John C. Lechleiter recently weighed in on the issue with respect to the pharmaceutical industry in offering his perspective on the importance of including data exclusivity provisions for biologics as found in US law for the Trans-Pacific Partnership (TPP), a regional free trade pact in Asia under negotiation.

	Emphasizing America’s advances in innovation over the past two centuries, Lechleiter asks in an

, “how [do we] best sustain America’s capacity for innovation in the face of accelerating global competition?” Lechleiter believes the TPP is a vital channel that will lower barriers among nations, boost investment, and broaden the reach of products and services. Investors, according to Lechleiter, will be “more likely to risk ample capital…if they know that the markets for the products that follow are large and welcoming.” Also, emphasizing the importance of job growth, Lechleiter points out that the biopharmaceutical industry “supports some four million American jobs” that spurs biomedical research and has “kept us in a position of global leadership in this important sector. The TPP can expand America’s capacity for innovation, help create jobs here at home, and extend the reach of life-saving medicines to patients everywhere,” says Lechleiter.

	In welcoming the benefits of free trade, however, Lechleiter also raised some concerns in considering the TPP. Lechleiter stresses the need for strong intellectual property protections, citing the US’s Affordable Care Act, and believes that nations involved in TPP should commit to a 12-year data protection period similar to US law.  He believes the US and other countries involved in TPP negotiations will set the standards for countries, such as China, that are not part of the agreement. “We cannot sacrifice the fundamental incentives that drive biomedical R&D investments,” he says in the op-ed piece.

	Looking to improve access to the Asia-Pacific Economic Cooperation (APEC) group market, the US is participating in the TPP along with more than 10 other countries. Canada and Mexico recently joined the trade talks earlier this month. The US Chamber of Commerce has 

 that the TPP “represents a vital opportunity to ensure that American exporters have access to the world’s most dynamic economies” and recommends that negotiations exclude no products or sectors, establish strong intellectual property rules, break regulatory barriers, and create due process on antitrust enforcement.

	As the pharmaceutical industry continues to globalize and new markets become increasingly important for industry growth, balancing free trade and innovation and safeguarding intellectual property make for sound policy.

The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy.

Eli Lilly Chairman Stresses the Importance of Biopharmaceutical Innovation on the Economy

 October issue) raises that very question.  Earlier this year, the 

 reported that FDA had tracked employee emails in its investigation into the possible leak of agency information by FDA scientists who complained about the agency’s medical device review process. These scientists raised concerns about radiation danger levels.

	This situation is disconcerting on a few levels. First, and most important in my opinion, is the initial problem of a potentially faulty review process that may have allowed unsafe medical devices to reach patients. Second, and certainly a concern for manufacturing companies, is the potential leak by FDA employees of confidential data that had been submitted to FDA with the assurance that it would stay within the agency. And third, is the fact that a government agency may have violated the private correspondence, some of which may be protected under whistleblower laws, of its employees.

	Were the FDA staff members who allegedly leaked confidential company data right for doing what they did? Pharmaceutical companies rely on FDA to protect confidential scientific data that may be crucial to their future business; however, employees should feel safe to express important concerns. Ultimately, it is FDA’s job to protect health. It’s a sticky situation that should be addressed.

	Does FDA need to have a better system in place for employees to voice concerns while also protecting confidential data?

An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question.