GlaxoSmithKline Manufacturing Problems Show Problem Of Drug Safety
Winnipeg, Manitoba - The president of http://www.UniversalDrugStore.com, a leading mail order pharmacy, says that the announcement by GlaxoSmithKline that it is unable to provide certain drugs because of what it calls "manufacturing difficulties", shows that the real challenge of ensuring the safety and efficacy of pharmaceuticals lies with oversight of the manufacture of the drugs, not restricting Americans' access to prescriptions from licensed, registered pharmacies outside the U.S.
Jeff Uhl cites a recent letter in which GlaxoSmithKline says that it is unable to fill customer orders for PAXIL(R) tablets, COREG(R) tablets and RELAFEN(R) tablets due to what the company describes as "recent manufacturing difficulties."
Uhl observes that the FDA earlier this year suspended the manufacture of PAXIL CR(R) and AVANDAMET(R) by GlaxoSmithKline because the company failed to meet FDA manufacturing standards. The substandard pills reportedly split apart, causing patients to receive a portion of tablet either without any active ingredient or a portion with no controlled-release property."
"GlaxoSmithKline does not identify its recent 'manufacturing problems,' but one can only wonder if the company is referring to the FDA suspension or related problems with other products," Uhl says.
"In any case, the suspension of the GlaxoSmithKline products is significant because it is the latest in a series of actions by the FDA against pharmaceutical manufacturers in recent years," Uhl notes, citing actions in which the FDA reprimanded Schering-Plough, Eli Lilly, Wyeth and Abbott Laboratories.
"GlaxoSmithKline's problems remind us that the answer to drug safety and efficacy lies in proper FDA oversight of the manufacture of pharmaceuticals, not the harassment of America's seniors and others through discretionary seizures of shipments of prescription drugs," Uhl says.
Uhl notes that the FDA suspension against GlaxoSmithKline and the company's manufacturing problems come at a time that many Canadian-based mail- order pharmacies are witnessing stepped-up seizures by the FDA and customs officials at major airports such as Los Angeles and New York LaGuardia.
"Pharmaceutical manufacturers continue to make false charges regarding the safety of prescription drugs from Canada and other countries, creating a rationalization for a diversion of FDA resources to seizures that restrict Americans' access to safe, lower-cost prescription drugs. This diversion distracts the FDA from its responsibility of ensuring that the drug manufacturers are meeting their legal, ethical and moral responsibilities to the American public," Uhl says.
Uhl says GlaxoSmithKline's substandard practices put patients who have not received their proper prescription medication at risk because they must seek replacement drugs. He notes that GlaxoSmithKline has laid out a schedule for when the drugs might again be available, but that GlaxoSmithKline also warns that it might be necessary for patients to consult with pharmacists or physicians to seek replacement drugs.
Uhl pledged that http://www.UniversalDrugStore.com stands ready to assist any patients adversely affected by the shortage caused by GlaxoSmithKline's current manufacturing difficulties.
SOURCE: Universal Drugstore Ltd.