House committee to hold hearing over J&J recall
WASHINGTON House Committee on Oversight and Government Reform chairman Ed Towns, D-N.Y., on Thursday announced that the committee will hold a hearing Sept. 30 at 10 a.m. to examine the circumstances surrounding Johnson & Johnson’s recall of more than 135 million bottles of infant and children’s medicines produced by Johnson & Johnson/McNeil Consumer Healthcare, including children’s Tylenol, infant’s Tylenol, children’s Motrin and children’s Benadryl.
The hearing also will examine the circumstances surrounding a “phantom recall” of a particular Motrin product, which became public as a result of the committee’s hearing on May 27.
“This is about the safety of trusted medication that our children and grandchildren use,” Towns stated. “The evidence we have uncovered since our first hearing is extremely troubling.”
Witnesses invited to testify include Bill Weldon, J&J chairman and CEO, and Colleen Goggins, J&J worldwide chairman, consumer group.
The hearing will be webcast on the committee’s website, Oversight.house.gov.
FDA advisory committees forgo restricting cough-cold sales, CHPA responds
WASHINGTON A pair of Food and Drug Administration advisory committees on Tuesday evening recommended that the FDA not place greater sales restrictions on the sale of dextromethorphan by placing the ingredient on the controlled substances schedule. The panel of FDA advisers voted to not schedule DXM by a vote of 15-9.
"Today’s FDA advisory committee decision not to recommend scheduling [over-the-counter] cough medicines containing dextromethorphan as a controlled substance reflects a sound balancing of the benefits of over-the-counter medicines containing dextromethorphan,” the Consumer Healthcare Products Association stated in a release following the decision. “Because of cough’s widespread prevalence and effects, it’s vital for people to have OTC access to safe and effective self-treatment. Dextromethorphan is in nearly 90% of OTC cough suppressants sold today,” the statement read.
"We do, however, recognize the need for continued education to keep any abuse levels low,” the CHPA added. “We also have long called for federal legislation that would limit purchases of bulk quantities of dextromethorphan to manufacturers who are registered with FDA. We believe that a statutory ban on sales of dextromethorphan medicines to those under 18 [years of age] would limit abuse.”
H.D. Smith signs prime vendor agreement with U.S.-based Nigerian pharmacy group
CINCINNATI and SPRINGFIELD, Ill. A large group of Nigerian-owned independent retailers has struck a new, three-year prime vendor agreement with H.D. Smith, a leading national pharmaceutical wholesaler.
H.D. Smith and the Nigerian Association of Pharmacists and Pharmaceutical Scientists in America said the deal would bolster both groups. Under terms of the contract, H.D. Smith will become the primary supplier of pharmaceutical products for the more than 100 U.S. pharmacies that are NAPPSA members. The supply agreement begins immediately and extends through June 30, 2013.
“We are excited and proud of this accomplishment, and hope it is only the beginning of more to come,” said NAPPSA Nnodum Iheme. “Since success breeds success, we anticipate more Nigerian-owned pharmacies to join or partner with NAPPSA.”
H.D. Smith chairman and CEO Dale Smith also expressed satisfaction with the agreement. “The decision to select a primary vendor does not come lightly and demands close inspection of services, programs and reputation,” Smith said. “We seek to enhance NAPPSA members’ success.”
NAPPSA is an umbrella organization of Nigerian pharmacists, pharmaceutical scientists, allied scientists and academics in the Americas. “Among other objectives, NAPPSA fosters cooperative efforts among relevant educational, research, industrial, commercial and governmental entities; propagates critical information in the medical, biological, pharmaceutical and related healthcare-technology fields, for the optimization of health outcomes,” the group noted in a statement.
H.D. Smith markets itself as “the largest privately held national full-line, full-service wholesaler that provides a complete line of pharmaceuticals, OTCs, HBAs, home healthcare products, durable medical equipment, seasonal merchandise and a wide array of marketing programs to retail pharmacies, regional chains and health systems.”