SPAARx establishes Metro D.C. office
ARLINGTON, Va. — A specialty pharmacy industry group has established new offices near the nation’s capital.
The Specialty Pharmacy Association of America announced the new offices are located in Arlington, Va. SPAARx’s new office will open on Tuesday in the Ballston area of the city.
"Having already addressed critical issues facing specialty pharmacy stakeholders, such as HI-TECH legislation and other regulatory concerns, SPAARx looks forward to further advancing its current dialogues and establishing new relationships in a collaborative manner with the variety of pharmacy organizations and others in the metro D.C. area," SPAARx COO Kevin Alder said. "SPAARx will continue to work in advocating and advancing the knowledge and understanding of specialty pharmacies and its role in providing patient access to needed treatments and quality to both the legislative and regulatory decision makers."
Auxilium, Vivus in deal worth up to $300 million for erectile dysfunction drug
CHESTERBROOK, Pa. — Auxilium Pharmaceuticals will have exclusive rights to market a drug for erectile dysfunction in the United States and Canada, under a new licensing agreement with the drug’s manufacturer.
Auxilium announced the deal with Vivus for Stendra (avail). Under the license, Auxilium will pay Vivus a one-time license fee of $30 million. If the Food and Drug Administration approves a change to the drug’s label to reflect an onset of the drug’s effecting 15 minutes or less, Auxilium will pay a $15 million milestone payment, as well as royalties and up to $255 million in potential milestone payments based on various sales goals.
"We believe Stendra complements our current portfolio of testosterone replacement therapy and [erectile dysfunction] products, further broadening our men’s healthcare franchise in a very large market segment consisting of patients that tend to switch among products," Auxilium president and CEO Adrian Adams said. "We believe the unique features of Stendra, including its dosing interval [of] 30 minutes prior to sexual activity, ability to take with or without food, modest alcohol consumption requirements and a favorable side effect profile make it an exciting entrant into the category."
Maine law arouses concerns about security of drug supply chain
A new law in Maine will allow the importation of drugs from abroad through mail-order from some pharmacies, formalizing a practice that has existed in many parts of the country for several years, and marking the first time a state government has, by law, gone against Food and Drug Administration regulations that bar importation of drugs.
Bloomberg columnist Megan McArdle said Maine was "going rogue" on drug importation, and that pretty much sums it up. The state, which has long had a close relationship with Canada — its governor, Paul LePage, is of French-Canadian descent and spoke Quebecois French as his first language — is openly defying federal law. And because federal law ultimately trumps state law, it’s likely the federal government will crack down at some point.
Already, the law is the subject of a suit in federal court. Last month, the Maine Pharmacy Association, the Retail Association of Maine, the Maine Society of Health System Pharmacists and several individual pharmacists joined the Pharmaceutical Research and Manufacturers of America in a lawsuit in the U.S. District Court in Bangor, Maine, to try and overturn the law. LePage and other supporters of the law have brushed off objections as drug companies attempting to protect their "turf."
But this isn’t all just about businesses attempting to protect their interests. There are also serious concerns about safety at play.
According to an analysis of a report from the Group of 8 about rogue online pharmacies by the Partnership for Save Medicines, 70,000 fake prescription pills were discovered in the United Kingdom’s secure supply chain last year, and another 30,000 pills remain unaccounted for by the Medicines and Healthcare Products Regulatory Agency, the country’s equivalent to the FDA. The trouble is, the United Kingdom is one of the countries from which the Maine law allows drug imports. The others are Australia, Canada and New Zealand.
As mentioned before, Maine’s law formalizes practices that are in existence. Since 2004, the city of Portland, Maine, has obtained drugs through CanaRx, a broker based in Canada. The company also supplies to public-sector health plans in Illinois, Rhode Island and Vermont.
To be fair, it’s hard not to see where Portland and LePage are coming from: The city saved $3.2 million between 2004 and 2012 through its CanaRx partnership. The United States is the only industrialized country that doesn’t control drug prices, and concerns about cost are a major factor in medication non-adherence. So it’s no surprise that many patients and payers have sought to go elsewhere to find bargains.
CanaRx has had its share of problems as well. In 2003, it received warning letters from the FDA that its practices violated U.S. law, and currently, its physical presence in the United States appears limited to a post office box in Detroit. A call to CanaRx was not returned.
According to the company’s website, "medications shipped from CanaRx meet the same strict manufacturing requirements as those sold in the U.S. and are government regulated. Although the drugs you receive may look slightly different or have a different name than the one you are used to, for all intents and purposes they are identical. For example, a drug may be a capsule in the U.S. but a tablet in another country."
But the FDA doesn’t buy these explanations. "Notwithstanding these assertions, Canadian and other foreign versions of FDA-approved drugs are generally considered unapproved in the United States," read a follow-up to the 2003 letter, addressed to CanaRx president G. Anthony Howard and Syracuse, Ind.-based regional manager Joseph Todd. "This is so because FDA approvals are manufacturer-specific, product-specific, and include many requirements relating to the product, such as manufacturing location, formulation, source and specifications of active ingredients, processing methods, manufacturing controls, container/closure system, and appearance … Frequently, drugs sold outside of the United States are not manufactured by a form that has FDA approval for that drug."
To be sure, there are few doubts about the safety of Canada’s legal drug supply chain or the legitimate drugs sold there, and the same can be said of most other developed countries. But the issue isn’t about whether a prescription picked up at a drug store in Toronto is safe. The issue is about counterfeit or adulterated drugs making it into the U.S. supply chain by coming into the country through channels the FDA can’t regulate.