- Drugmakers ‘hijacked’ the FDA’s orphan system to score premium pricing on mass-market meds: report
There’s no denying that financial incentives for orphan drug development spawned meds that have saved hundreds of thousands of lives. But they’ve also helped mass-market drugmakers rack up millions in incentives, tax breaks and patent-protected profits—in some cases through monopoly pricing...About one-third of the orphan drug approvals the FDA doled out since the program began more than 30 years ago have been for repurposed, large-market products or drugs with multiple orphan green lights...Best-sellers such as Crestor…,Abilify…,Herceptin…,and Humira...fall into the category of big sellers whose makers snagged millions in government incentives—not to mention seven years of exclusive rights on the market—when they resubmitted their therapies as treatments for smaller populations...What we are seeing is a system that was created with good intent being hijacked…Repurposing a drug isn’t necessarily a bad thing, of course, if it can help get a treatment to additional patients...But when the orphan incentives allow competition-free drugmakers to charge whatever prices they want for their meds?...Now...it seems like...this practice may be driving up prices...Industry lobby groups...are unsurprisingly in favor of maintaining the status quo. With rare diseases “tragically killing and brutalizing mostly children,” incentives for orphan drugmakers should be kept in place...the risk of losing incentives in the system far outweighs the benefit of trying to save a few pennies on the health care dollar...
- Alkermes’ schizophrenia drug Aristada gets FDA nod (reuters.com)
Food and Drug Administration…approved Alkermes Plc's longer-acting injectable version of … schizophrenia pill Abilify (Aristada,aripiprazole lauroxil), making the treatment available in two doses…Abilify, developed by Japanese drugmaker Otsuka Pharmaceuticals and sold…by Bristol-Myers Squibb Co, is already facing generic competition.
- Bristol-Myers Squibb to pay $19.5 million to settle off-label promotion case (reuters.com)
Drugmaker Bristol-Myers Squibb Co will pay $19.5 million to resolve multi-state allegations that it improperly promoted a schizophrenia treatment for uses not approved by the U.S. government, New York Attorney General Eric Schneiderman said...The company's agreement with 42 other states and the District of Columbia centers on charges that Bristol-Myers Squibb promoted its Abilify anti-psychotic drug for use in children and elderly patients with dementia and Alzheimer's disease...Besides addressing the off-label promotion allegations, the settlement also resolves charges that the company violated state consumer protection laws by misrepresenting side effects such as metabolic weight gain.
- 10 Best-Selling Brand-Name Drugs in 2015 (pharmacytimes.com)
10 best-selling brand-name drugs have generated $48.5 billion in sales this year through June 2015,…gross sales from the following 10 drugs comprise 43% of the nearly $112.5 billion in total drug sales generated by the 100 best-selling drugs..
- Humira (Abbott) - $8.6 billion
- Abilify (Otsuka) - $7.2 billion
- Enbrel (Amgen) - $6.1 billion
- Crestor (AstraZeneca) - $6.1 billion
- Lantus Solostar (Sanofi-Aventis) - $5 billion
- Sovaldi (Gilead Sciences) - $4.9 billion
- Advair Diskus (GlaxoSmithKline) - $4.8 billion
- Nexium (AstraZeneca) - $4.7 billion
- Januvia (Merck) – $3.8 billion
- Lyrica (Pfizer) - $3.4 billion
- Makers of Abilify drug settle with 43 states, including Nevada, for $19.5M (reviewjournal.com)
Nevada is expected to receive nearly $300,000 in a multistate settlement with a pharmaceutical company accused of marketing a drug to patient groups for which they didn’t have federal approval and mischaracterizing the drug’s risks...Bristol-Myers Squibb Company, which partnered with Otsuka America Pharmaceutical, Inc. to market antipsychotic drug Abilify, settled with 43 states for $19.5 million, according to an announcement Thursday by the office of Nevada Attorney General Adam Laxalt...The company was accused of marketing the drug to seniors with Alzheimer’s disease and dementia despite the fact the drug wasn’t approved for those purposes by the U.S. Food and Drug Administration...
- The top 10 most-advertised prescription drug brands (fiercepharmamarketing.com)
Pharma ad spending soared to $4.5 billion in 2014, backing branded drugs in levels not seen since the recession, with particular emphasis on blockbusters--and wannabes. Drugmakers poured $3.4 billion into advertising spending on the top 10 drugs, which accounted for 75% of the spent on all advertising of pharmaceuticals,.
- Cialis : $249 million
- Lyrica : $229 million
- Eliquis : $219 million
- Viagra : $211 million
- Humira : $203 million
- Latuda : $179 million
- Xeljanz : $161 million
- Celebrex : $119 million
- Abilify : $108 million
- Chantix : $103 million