NABP report: Rogue pharmacies prolific
At some point in their lives, most people learn the old lesson about things that look too good to be true, sometimes by hearing it from others, and other times from bad experiences.
It should be hoped that nobody learns that lesson the hard way by buying prescription drugs that carry a high risk of being counterfeit, adulterated or otherwise unsafe to use from one of the thousands of rogue websites that sell them. Rogue Internet pharmacies occupy the online equivalent of that dark alley people usually know better than to enter. Luckily, however, some light is being shown on these rogue websites these days.
Last month, a report by the National Association of Boards of Pharmacy indicated that 97% of the more than 10,000 online drug sellers it surveyed are doing business outside the law. The report, “Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: October 2012,” noted that 9,543 websites appeared to be affiliated with networks that obtain drugs from “questionable sources,” among other findings. The report concluded that it was important for members of the international pharmacy community to protect patients worldwide from the potential dangers of illegal online drug sellers, noting that the illegal sites provide a way to sell counterfeit drugs, while also highlighting collaborative efforts with organizations and government agencies around the world that have resulted in the exposure and shutdown of thousands of rogue pharmacy sites.
The federal government has stepped in as well. In September, the Food and Drug Administration launched BeSafeRx, an education campaign to discourage purchasing from rogue sites by providing such information as the tactics rogue sites use to appear legitimate. “Buying medicines from rogue online pharmacies can be risky because they may sell fake, expired, contaminated, not-approved-by-the-FDA or otherwise unsafe products that are dangerous to patients,” FDA commissioner Margaret Hamburg said. “Fraudulent and illegal online pharmacies often offer deeply discounted products. If the low prices seem too good to be true, they probably are.”
But according to a report released earlier this year by Portland, Ore.-based LegitScript, a company that verifies online pharmacies, rogue pharmacy operations appear to be highly organized. In March, LegitScript released a report showing that as many as one-third of rogue pharmacies were hosted under one Internet domain registrar, Internet.bs, a company registered in the Bahamas and based in Panama. Internet.bs is one of about 450 domain name registrars accredited by the Internet Corporation for Assigned Names and Numbers and accounts for only 0.2% of total registered domains online, but between 32.9% and 44% of the rogue online pharmacy domains and 20 registrars account for 81% of the rogue sites.
And a problem intricately related to rogue pharmacies remains as well: counterfeit drugs. In May, the FDA warned that counterfeit versions of Teva’s attention deficit hyperactivity disorder drug Adderall were circulating online. This came two months after Congress passed S. 1886, the Counterfeit Drug Penalty Enhancement Act. In September, the same day the FDA announced the launch of BeSafeRx, the agency, the Generic Pharmaceutical Association, the Pharmaceutical Research and Manufacturers of America and others took part in a conference to find ways to stop the spread of counterfeit drugs, sponsored by the Partnership for Safe Medicines. “In an increasingly global society, heightened cooperation and information sharing between stakeholders around the world is an invaluable tool … ,” Partnership for Safe Medicines treasurer Tom Kubic said. “And as more allies join our cause, we are better able to spread our message and educate the public at large about the extreme risks of counterfeit medicines and how to protect themselves and their families.”
Click here for the full 2012 Generics Report.
NewsBytes — Chain Pharmacy, 11/19/12
FDA approves Par leukemia drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.
Par said Oct. 25 that the FDA had approved Anchen Pharmaceuticals’ tretinoin capsules in the 10-mg strength.
The drug is a generic version of Roche’s Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.
Federal court orders FDA to allow Watson diabetes drug launch; Mylan challenges ruling
PARSIPPANY, N.J. — A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.
Watson said the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson, ruling that the FDA would have to approve its generic version of Takeda’s Actos (pioglitazone hydrochloride) tablets in the 15-mg, 30-mg and 45-mg strengths. Mylan is challenging the decision.
Mylan, the world’s second-largest generic drug maker, filed a motion to stay the court’s order. “Mylan is disappointed in [the] ruling regarding pioglitazone, and we believe the court erred in its decision by directly contravening the Hatch-Waxman Act,” Mylan CEO Heather Bresch said, referring to the 1984 law that created an abbreviated approval pathway for generic pharmaceutical drugs.
“Mylan does not believe Watson is entitled to participate in Mylan’s 180-day exclusivity period in relation to this product, and we intend to pursue this case vigorously, including seeking expedited relief from the appellate court if necessary.” Watson filed suit against the FDA in August 2012, alleging that an agency decision to deny Watson’s claim to shared exclusivity in marketing a generic version of Actos would improperly delay its launch of the drug. Actos had sales of about $2.7 billion during the 12-month period ended in May, according to IMS Health.
FDA approves generic Lupin
MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said on Oct. 18.
Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.
The drug is a generic version of Teva’s branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.
FDA approves Sandoz dermatology medication
PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Sandoz for treating symptoms of various skin diseases.
Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval of desoximetasone ointment in the 0.25% strength. The drug is a generic version of Taro Pharmaceutical Industries’ Topicort and, according to Sandoz, is the first Fougera dermatology product Sandoz has launched since its $1.5 billion acquisition of the company in May 2012.
Topicort and its generic versions had sales of $36.5 million during the 12-month period that ended in August 2012, according to IMS Health.
Generics target specialty pharmacy with biosimilars
Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.
All right, maybe that’s a little too dramatic, but the so-called “patent cliff” is here. But unlike Thelma and Louise, it’s not too late for drug makers to adapt to an environment in which the supply of top-selling primary-care drugs with expiring patents begins to dwindle, leaving entire disease-state categories commoditized.
“Eventually, that patent cliff will not be there,” IMS Health VP industry relations Doug Long told Drug Store News. “When you have a brand innovation drought, particularly in primary care or pill forms, eventually that will create a generic small molecule opportunity drought, and that’s likely to happen at the end of the decade.”
The response for both generic and branded drug makers has been to move up the value chain, Long said, which includes moving into specialty drugs for diseases like cancer and autoimmune disorders.
According to IMS Health, the specialty drug market was worth $42.8 billion during the 12-month period ended in June, and according to Medco Health Solutions, now part of Express Scripts, specialty pharmacy costs could account for 40% of drug spending by 2020. So it should come as no surprise that a huge number of drug makers, retailers and others hope to grab a piece of it.
One of the ways generic drug makers hope to do this is with biosimilars. The Patient Protection and Affordable Care Act included a mandate for the Food and Drug Administration to create an abbreviated regulatory approval pathway for biosimilars, similar to the one for generic pharmaceutical drugs that the Hatch-Waxman Act created 28 years ago.
The regulations aren’t in place yet, but some drug makers aren’t content to wait — and some are seeking approval for biosimilars using the pathway for novel biologics already in place. At the end of August, the FDA approved Teva Pharmaceutical Industries’ tbo-filgrastim for treating neutropenia, a condition in which the number of white blood cells is decreased, making patients more susceptible to life-threatening bacterial infections. The company sought approval using a biologics license application, or BLA, the same approval pathway used for novel biotech drugs because while the Patient Protection and Affordable Care Act created a regulatory approval pathway for biosimilars, the regulations have not yet been established. Teva markets tbo-filgrastim in Europe under the trade name Tevagrastim, which is a biosimilar version of Amgen’s Neupogen. Teva plans to market tbo-filgrastim starting in November 2013, under an agreement with Amgen.
Another area of opportunity in the future will be oral solids for cancer. Most of those drugs are brand-new and won’t lose patent protection for at least a decade. “The chance for generic entry is some place off in the future, but then that will still follow the same pattern,” Long said.
Click here for the full 2012 Generics Report.