Titan Medical Enterprises shut down after violating drug, supplement good manufacturing practices
SILVER SPRING, Md. — A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration reported Friday.
U.S. District Judge Otis Wright of the Central District of California signed the order on Dec. 11, 2012, against Titan Medical Enterprises and James McDaniel, Titan Medical’s owner and president. The order was entered in response to a complaint filed by the U.S. Department of Justice, on behalf of the FDA.
The court found that the company and McDaniel violated the Act by failing to follow current Good Manufacturing Practice for drugs and for dietary supplements. The court also found that the defendants violated federal law by distributing unapproved new drugs. Prior to entry of the court’s order, Titan Medical Enterprises manufactured and domestically distributed a variety of drugs and dietary supplements.
“The FDA continues to take strong enforcement actions against companies that fail to comply with federal drug and dietary supplement manufacturing regulations,” stated acting associate commissioner for regulatory affairs Melinda Plaisier. “The actions we are taking are necessary to make sure that the drugs and dietary supplements consumers purchase have been manufactured in compliance with cGMP."
Nine FDA inspections of Titan between 2001 and 2012 revealed that the company’s drugs were not manufactured and distributed in compliance with Drug cGMP. Violations included failure to establish an adequate written testing program to assess the stability of finished products and failure to establish and follow adequate laboratory controls.
The Dietary Supplement cGMP regulations went into effect in 2007 and became effective over the following three years based on company size. Titan’s compliance date was in 2010, and FDA inspections in 2010, 2011, and 2012 revealed that Titan violated the Dietary Supplement cGMP regulations by, among other things, failing to verify that a subset of finished dietary supplement batches met product specifications and failing to adequately confirm the identity of dietary supplement components.
Drug cGMP includes practices and systems required to be adopted in the manufacture and testing of pharmaceuticals. Drug cGMP outlines the aspects of production and testing that can impact the quality of a product.
Similarly, Dietary Supplement cGMP regulations require dietary supplement manufacturers to ensure quality in their dietary supplements by appropriately controlling all aspects of their processes and procedures to ensure a supplement meets minimal quality standards and is not adulterated by the presence of contaminants.
Like this story? Find us on Facebook for more insight, analysis and the latest in drug store news. Join the conversation.
Rx-to-OTC switches could be boon as FDA looks at switch paradigm
A new report by Francesco International identified $35.7 billion worth of potential Rx-to-OTC switches in a wide range of indications, from hypertension and chronic obstructive pulmonary disorder to high cholesterol and erectile dysfunction, and the Food and Drug Administration has been looking at ways technology and pharmacists could be employed to ensure that patients taking drugs new to the consumer health space take them appropriately.
With growth in traditional pharmaceuticals expected to slow down significantly, a growing number of drug makers — branded and generic alike — see specialty drugs as their main sources of revenue for the foreseeable future. At the same time, those drug makers not invested in specialty may be looking for growth opportunities in consumer health.
Indeed, while much was made of how Pfizer gained control of Wyeth’s specialty drug business when it acquired that company in 2009, or how Merck got Schering-Plough’s specialty business in the same way, both mega-deals also turned Pfizer and Merck into consumer health companies, as Wyeth and Schering-Plough had a significant presence in the space. And while Sanofi’s acquisition of biotech giant Genzyme got plenty of attention, equally important was when the French drug maker — already a player in the OTC space — purchased OTC maker Chattem.
The FDA’s Nonprescription Safe Use Regulatory Expansion initiative could soon open the door to a whole new world of OTC opportunities for traditional drug makers. According to Francesco’s report, more than half of patients with hypertension don’t have their condition under control, and people with diabetes and COPD face similar problems.
At the same time, Rx-to-OTC switches have often been tricky to accomplish. While switches for antacids and allergy drugs have been relatively easy — Zegerid and Allegra stand out as recent examples — Merck’s efforts to get an OTC switch for its cholesterol-lowering statin Mevacor were unsuccessful. Meanwhile, some local and state governments have sought OTC-to-Rx switches for drugs with pseudoephedrine in an effort to stem problems with methamphetamine abuse.
A major issue, however, has been concerns about safety and whether patients can be trusted to self-diagnose and use certain drugs appropriately. A patient taking a prescription drug does so under the watchful eyes of a prescriber and a pharmacist, but a patient taking OTC medications doesn’t get that kind of scrutiny and must therefore often determine independently when it’s a good time to take the drug and how much to take.
That helped sink the efforts to get Mevacor switched, as FDA officials decided that patients could not be trusted to know when and when not to use the drug. According to one study that appeared in 2008 in the New England Journal of Medicine, 30% of patients who thought they needed Mevacor in fact had a risk of a heart attack or other cardiovascular problems of less than 5%. More recently, in November 2012, the FDA’s Nonprescription Drug Advisory Committee voted 6-to-5 to advise against an OTC switch for Merck’s overactive bladder patch Oxytrol, saying that consumers would have a difficult time self-diagnosing an overactive bladder, that symptoms of the condition could indicate more serious diseases like diabetes, and that men might inappropriately choose to use it as well.
In September 2012, a study sponsored by CVS Caremark and published in the Journal of the American Medical Association found that consumers heard less about risks when prescription drugs were switched to OTC, as advertisements for OTC versions of the drugs had significantly less information about potential risks, with only 11% of them discussing the risks, compared with 70% of ads for prescription-only drugs.
Nevertheless, the FDA continues to actively look at OTC switches — in September 2012, Kalorama Information reported that many applications for switches were under review at the agency, including categories new to the consumer health space, such as bacterial infections, cholesterol and hypertension. And in March 2012, Center for Drug Evaluation and Research director Janet Woodcock told attendees of a conference on OTC switches that the agency wasn’t looking to change the switch process itself, but to see how it could incorporate technology and pharmacists into efforts to improve access, such as instructional videos, and requirements for a pharmacist consultation or diagnoses before patients could receive certain nonprescription drugs.
While safety is and ought to remain a top concern, allowing easier access to certain medications while ensuring they use them appropriately could help patients keep certain conditions under control more conveniently while also presenting a huge opportunity for retail pharmacies to boost sales in their OTC aisles and possibly get more attention for their pharmacists as well.
GSK Consumer names new director of corporate development
PITTSBURGH — GlaxoSmithKline has promoted Pam Prisk to director of corporate development for GSK Consumer Healthcare North America, effective immediately.
"During Pam’s 17 years with GSK, she has gained outstanding experience through a variety of customer-focused roles with increased responsibilities in category management, sales strategy and shopper marketing," the company stated. "Pam’s experience and customer knowledge will enable her to get up to speed quickly to ensure we don’t lose any momentum in this critical function."
In her new role, Prisk will focus on championing strategic industry and customer initiatives within GSK. She will report to the director of commercial excellence Mike McClaine. "Commercial excellence is a new area for our business, which focuses on developing and implementing strategies to help us achieve our vision to become the ‘First and Best, Fastest Moving Consumer Healthcare Company’ driven by science and values," GSK added.
Like this story? Find us on Facebook for more insight, analysis and the latest in drug store news.