- FDA warns ‘critical’ drug shortages possible after Hurricane Maria battered Puerto Rico (usatoday.com)
Patients could experience "critical shortages" of key pharmaceuticals, the U.S. Food and Drug Administration is warning after Hurricane Maria brought Puerto Rico's drug manufacturing industry to a standstill...The FDA said...it is taking active measures to help redirect production and preserve existing treatments to avoid a ballooning health crisis from Maria's destruction...The agency did not identify any specific medications that could be at risk of a shortfall, and a spokesperson was not immediately available to provide details...But there are "several" cases where "we may soon face critical shortages if we don’t find a path for removal or ways to get production back up and running," FDA Commissioner Scott Gottlieb said in a statement...Some companies are beginning to move product off of the island, and they’ve been communicating with the FDA about that and what potential challenges and limiting factors they see ahead...Drugs made on the island include AstraZeneca's cholesterol treatment Crestor, Abbvie arthritis drug Humira and Johnson & Johnson-owned HIV drug Prezista. Those three companies have said supplies of their drugs are in good shape...the catastrophic storm wiped out electricity for the entire island, devastated telecommunications and made travel nearly impossible for many employees of the island's nearly 50 pharmaceutical factories...
- Spending On Drugs Will Drop As Top Sellers Go Generic (forbes.com)
...IMS Health disclosed that total spending on prescription drugs in 2015 rose 12.2% to almost $425 billion. Since drug pricing continues to be a major topic of discussion...What is striking about the newly released data are the drugs Americans spend the most on... cholesterol-lowering drug Crestor, with sales of $6.3 billion...this will soon become moot as Crestor will lose patent protection and become a generic drug, an event that will likely drive down its cost by as much as 90%...rheumatoid arthritis drug, Amgen’s Enbrel, with U.S. sales of $6.6 billion last year. The FDA is now reviewing a biosimilar version of Enbrel which was filed by...Sandoz...Given that Zarxio was launched at a 15% discount to Neupogen, a similar discount could be anticipated for a biosimilar Enbrel...rheumatoid arthritis, Humira (adalimumab) from AbbVie . Many analysts believe that Humira’s $10.6 billion in 2015 revenue will be severely impacted by biosimilars being developed by Merck, Amgen, Pfizer and others...one might expect even larger discounts than 15%...the top drug with respect to spending in the, the hepatitis C drug Harvoni from Gilead, weighing in at $14.3 billion. It is unlikely that the sales of this drug will decrease any time soon. However, the use of hepatitis C drugs to cure this infection will reduce the incidence of liver cancer, thereby lowering overall costs to the healthcare system over the coming years...there will be new–and expensive–breakthrough drugs emerging from the pipelines of the biopharmaceutical industry. But let’s not lose sight of the fact that these same drugs that save lives or alleviate the suffering of millions, eventually will become a lot cheaper.
- 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...
- Patent Expirations Of Crestor And Zetia And The Impact On Other Cholesterol Drugs (forbes.com)
...2016 will see a number of drugs going off patent...most notable are the patent expiries for two major LDL-cholesterol lowering drugs: the statin, Crestor...and the cholesterol absorption inhibitor, Zetia...However, the availability of generic ezetimibe and rosuvastatin could have other impacts. There are a number of people who cannot tolerate statins because of side-effects such as muscle pain. Statin intolerance, in fact, is a driver for companies seeking novel LDL-c lowering drugs in order to provide patients with alternatives. But that road has gotten harder...the most compelling new LDL-c drugs are the PCSK-9 inhibitors...These medicines have the ability to lower LDL-c to levels unattainable by statins alone...PCSK-9 inhibitors are expensive drugs listing at more than $14,000/year/patient...There is no doubt that the loss of exclusivity for Crestor and Zetia will impact the bottom lines of AstraZeneca and Merck, respectively...the availability of the generic forms of these drugs will also have an impact on physician prescribing habits and even drugs not yet on the market. Containing prescription drug costs is a major priority these days, and the use of generics is a key lever in accomplishing this, particularly in the face of high costs alternatives...
- AstraZeneca sues FDA to prevent generic versions of Crestor (statnews.com)
Drug makers generally don’t complain when regulators widen the market for their medicines. But AstraZeneca filed a lawsuit...claiming the Food and Drug Administration is on the verge of illegally broadening the indication for its best-selling Crestor cholesterol pill, and the move would unfairly allow generic competition...The argument, which the company also made late last month in a citizen’s petition, hinges on the interpretation of federal law governing product labeling. Depending upon the outcome, AstraZeneca may either maintain a monopoly on Crestor for another seven years or face lower-cost rivals to a key revenue stream when the Crestor patent expires on July 8...the drug maker won FDA approval to sell Crestor to treat children with a rare genetic disorder called homozygous familial hypercholesterolemia...Under the Orphan Drug Act, the company was awarded an additional seven years of marketing exclusivity for Crestor, but only for treating this particular rare...disease...Several generic companies are lined up to sell a version of Crestor. AstraZeneca argues that a generic must include all pediatric labeling information approved for the corresponding brand-name drug. The company filed its lawsuit over concerns that the FDA will, instead, rely on a decision it made last year allowing generic companies to exclude certain information, so long as a safety risk is not created...AstraZeneca...believes federal law entitles the company to an additional exclusivity period of seven years for Crestor in the US...the American Journal of Clinical Oncology, a team of researchers argued that drug makers are exploiting loopholes in the Orphan Drug Act that allow them to widen the market for such drugs and distorting the original purpose of the law.
- 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