McNeil signs consent decree regarding manufacturing facilities
FORT WASHINGTON, Pa. — McNeil last week finalized the terms of a consent decree of permanent injunction with the Food and Drug Administration for manufacturing facilities operated by the McNeil Consumer Healthcare Division in Las Piedras, Puerto Rico; Fort Washington, Pa.; and Lancaster, Pa.
The consent decree is subject to approval by the U.S. District Court for the Eastern District of Pennsylvania.
Under the terms of the consent decree, the company will continue to operate the manufacturing facilities in Las Piedras and Lancaster. The company will work with an independent expert who will inspect these sites and issue recommendations. Based on these findings, the company will develop remediation plans to address observations identified by the independent expert. These plans will be submitted to the FDA and are subject to the agency’s approval.
In addition, the company and the FDA have agreed on a plan to have the independent expert review certain manufacturing records at the two sites while remediation is ongoing to ensure that products released from the sites continue to meet quality standards.
The company expects that the consent decree will govern its operation of the facilities for a period of at least five years following the completion of the remediation plan.
In April 2010, McNeil voluntarily closed its manufacturing facility in Fort Washington, Pa., and announced that it would not re-open the plant until it completed its planned remediation efforts at that facility. According to the terms of the consent decree, the company will not re-open the Fort Washington facility unless it first completes remediation efforts at the facility, receives a certification of compliance from an independent expert and then receives approval from the FDA.
“This is a strong but necessary step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity,” stated Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
The decree, filed by the U.S. Department of Justice’s Office of Consumer Litigation and the U.S. Attorney’s Office for the Eastern District of Pennsylvania, requires McNeil to destroy all drugs under its control that have been recalled from the Fort Washington, Las Piedras and Lancaster facilities since December 2009.
The decree becomes effective when it has been entered by the court, the FDA stated.
CHPA taps Paul Sturman as new board chairman
WASHINGTON — Members of the Consumer Healthcare Products Association last week elected Paul Sturman, president and general manager of Pfizer Consumer Healthcare, to chair the association’s board, the association announced Monday.
“I’m honored to take on this new role and work closely with the board, our allies and Capitol Hill to promote the importance of [over-the-counter] medicines and dietary supplements in the healthcare continuum,” Sturman said. “Shaping policies that continue to provide self-care solutions and cost-effective options is a top priority.”
“As our nation seeks cost-effective healthcare options, CHPA is committed to demonstrating the role, value and accessibility that over-the-counter medicines and dietary supplements provide in our healthcare delivery system,” stated Scott Melville, CHPA president and CEO. “Paul is a thoughtful and experienced industry leader who brings a keen strategic vision to the association, and a commitment to strong board governance and oversight.”
In addition to Sturman, the CHPA welcomed the following to its board: Chris Combe, Combe Inc. chairman; Colin Mackenzie, president of GlaxoSmithKline North America Consumer Healthcare; Daren Mazzucca, publisher of Meredith’s Midwest Living; Dennis O’Donnell, Matrixx Initiatives president and CEO; Paul Scoggins, Johnson & Johnson/Merck Consumer Pharmaceuticals general manager; David Wendland, VP Hamacher Resource Group; and Steven Woolf, EVP and CFO of Humco.
Sturman becomes CHPA’s 54th chair and succeeds Christopher DeWolf of Lil’ Drug Store Products. He earned his bachelor’s degree in biology and his master’s degree in business administration from Bucknell University.
New legislation looks to cut out ‘use-it-or-lose-it’ provision from FSAs
WASHINGTON — Reps. Charles Boustany, R-La., and John Larson, D-Conn., on Friday introduced bipartisan legislation that would eliminate the “use-it-or-lose-it” provision associated with flexible spending accounts.
Under the Medical Flexible Spending Account Improvement Act, FSA participants would be able to cash out and pay taxes on any remaining FSA balances at the end of the year. The IRS adopted the forfeiture, or “use-it-or-lose-it” provision, to prevent FSAs from being misused as tax shelters; however, a new $2,500 cap on FSA contributions set to begin in 2013 as required by the Patient Protection and Affordable Care Act addresses that concern separately.
“Americans want healthcare solutions that lower costs,” Boustany stated. “FSAs are a great place to start. These accounts should not penalize individuals who save for medical expenses. We should eliminate this provision and empower consumers to make prudent healthcare decisions.”
Larson added, “Now is the time to finally eliminate the use-or-lose provision. It is truly unfair that families must forfeit hard-earned dollars that they have reserved for health expenses if they remain in the account at the end of the year.”
Save Flexible Spending Plans, an advocacy campaign that works to promote the accessibility and use of FSAs, applauded the bill’s sponsors for their attention to the issue. “As the price of health care continues to climb, FSAs help millions of working Americans manage and hold down their out-of-pocket costs,” stated Joe Jackson, chairman of Save Flexible Spending Plans and CEO of benefits provider WageWorks.
“Unfortunately, the ‘use-it-or-lose-it’ rule creates an unnecessary risk for FSA participants and a deterrent for nonparticipants," Jackson added. "A change to this rule ensures that individuals will not be forced to use up or forfeit any remaining funds simply because their families’ needs did not match their predicted annual healthcare expenses.”