- FDA slams another Indian drug maker for serious quality problems (statnews.com)
If there is a surefire way to arouse the concerns of Food and Drug Administration inspectors, try this: take a notebook listing manufacturing problems, place it in plastic bags along with other paperwork, and toss them in a nearby scrap yard where the inspectors can find them...Here’s another approach: leave “unofficial notebooks,” which are used to track manufacturing activities, lying around an office so the inspectors can read how bacteria is present in the water system, but become puzzled when the problem is not cited in official company records...These were just two of several “serious breaches” of good manufacturing practices the FDA cited in a Dec. 23, 2015, warning letter sent to Cadila Healthcare...What else concerned the FDA?
- There were problems with the potency of warfarin made at one plant and Cadila agreed to temporarily suspend production.
- ...nine consumer complaints were lodged by way of pharmacies and distributors over potential product mix-ups.
- Several batches of active pharmaceutical ingredients failed an analysis, but Cadila never explored why this occurred.
- 5 Drugs That Actually Decreased in Price Last Year (pharmacytimes.com)
Not every drug saw a price increase in 2015, despite widespread media coverage suggesting otherwise... Much of the national drug pricing debate last year centered on steep cost increases, including Daraprim’s infamous 5000% overnight price hike under former Turing Pharmaceuticals CEO Martin Shkreli... But the year wasn’t all bad news for Americans filling prescriptions...An analysis from the prescription drug cost comparison site GoodRx reveals that the 30 of the 50 most common generic drugs actually decreased in price by the end of 2015...Here are 5 popular generics that actually dropped in price last year:
- Fluoxetine (Prozac): decrease 30.4%, costs an average of $5 for a 30-day supply.
- Montelukast (Singulair): decrease 19.9%, costs an average of $18 for a 30-day supply.
- Duloxetine (Cymbalta): decrease 10.4%, costs an average of $38 for a 30-day supply.
- Atorvastatin (Lipitor): decrease 8.2%, costs an average of $13 for a 30-day supply.
- Losartan (Cozaar): decrease 4.8%, costs an average of $9 for a 30-day supply.
- American Emergency Rooms Are Facing Critical Drug Shortages (psmag.com)Longitudinal Trends in U.S. Drug Shortages for Medications Used in Emergency Departments (2001–2014) (onlinelibrary.wiley.com)
The shortfalls reveal deep problems in the market forces that control drug supply and demand...Over the past 14 years, American emergency rooms have faced more than 600 drug shortages, according to an analysis published last week in Academic Emergency Medicine. Among those shortages were lacks of life-saving, one-of-a-kind drugs such as naloxone...it's not just emergency rooms, though emergency medicine might be especially affected because production of injectable drugs is the most likely to come up short...the...analysis found that more than half of the missing emergency meds were for acute or life-threatening conditions. In most cases, doctors could substitute another drug for the missing one, but they were unable to do so five percent of the time...Why do these shortages occur? In the database the emergency-room researchers analyzed, the most commonly cited reason was a drug-plant shutdown due to quality control problems. But there are likely deeper causes. Those who buy injectable drugs for hospitals tend to choose the cheapest generics, without paying attention to quality...Another theory: The way hospital drugs are purchased encourages only a few companies to make generics, so when one company's factories go down, there's no one around to make up for the shortfall.
- Will U.K.’s Big 3 Health-Care Stocks Bounce Back in 2016?: Chart (bloomberg.com)
Here’s what lies ahead in 2016 for each company:
- GlaxoSmithKline: CEO Andrew Witty will attend both the J.P. Morgan health-care conference in San Francisco and the World Economic Forum in Davos this month. Shares of the U.K.’s biggest drugmaker have tumbled more than 20 percent since mid-2013. With generics snapping at the heels of its best-selling lung drug Advair, Glaxo has been touting new medicines while shunning large-scale M&A deals.
- AstraZeneca: After spurning a takeover by Pfizer Inc. in 2014, CEO Pascal Soriot has built the company up with small- to mid-sized acquisitions and licensing deals, focusing on drugs for cancer, respiratory disease and diabetes. Generic versions of its blockbuster cholesterol pill Crestor will hit the market in May. Results from several key cancer drug trials are expected in the second half of this year.
- Shire: The smallest of the three companies is said to be in advanced talks with Baxalta Inc. to become the world’s biggest maker of rare-disease drugs. Shares have dropped 21 percent since Aug. 3, the day before its $30 billion offer for Baxalta was made public. On the product front, Shire awaits U.S. approval of a key drug for dry-eye disease called lifitegrast, expected late this year.
- Activists sue Ohio to get drug pricing measure on the ballot (statnews.com)"Ohio Drug Price Relief Act" Summary Petition (sos.state.oh.us)
In the latest skirmish over prescription drug pricing, consumer activists filed a lawsuit against Ohio officials for ordering a review of signatures collected for a ballot measure designed to lower the cost of medicines...The proposed measure, known as the Ohio Drug Price Relief Act, would require the state to pay no more for medicines than the Department of Veterans Affairs. Currently, the VA gets a 24 percent discount off average manufacturer prices. A similar measure recently qualified for the ballot in California, despite opposition from the pharmaceutical industry...The lawsuit was filed two days after Ohio Secretary of State John Husted demanded election officials conduct another review of more than 171,000 signatures. He took that step after attorneys for the Pharmaceutical Research & Manufacturers of America, the industry trade group, wrote a letter to Husted to question the validity of many of the signatures that had been submitted...Drug makers are not taking any chances. In California, for instance, a spokeswoman for the industry campaign to defeat the ballot initiative recently called the proposal “misleading and flawed.”...She also argued the measure will increase the prices of prescription drugs sold to veterans and many California consumers, and reduce choices of medicines available. At the same time, she maintained the measure will cost taxpayers “millions more in state bureaucracy and lawsuits because it will be virtually impossible to implement.”
- Promise Of High Prices Now Driving Biopharma R&D Investments (forbes.com)
Once again, the biopharmaceutical industry had another banner year in 2015...in comparing the approvals of 1996 to 2015, a lot has changed over the years...the vast majority of drugs approved in 1996 were small molecule drugs...The drug approvals for 1996 are a reflection of the corporate strategy and the research philosophy embraced by Big Pharma at the time: find drugs that would be utilized by physicians to treat millions of patients suffering from common ailments...The “blockbuster” business model back then focused on having moderately priced drugs broadly prescribed...Companies have not totally abandoned this approach. Last year saw the approval of drugs expected to be billion dollar blockbusters by virtue of treating big populations of patients...What is stunning, however, is to see the number of drugs approved for small or “niche” populations, where high revenues are expected to be generated not by patient numbers but by price. Nowhere is this more evident than in the 14 new cancer drugs...I suspect that, for those who suffer from rare diseases or from certain forms of cancer, this shift in biopharma’s R&D priorities has been welcomed. As shown by the 2015 drug approvals, the promise of favorable pricing did stimulate innovation and improved the health of many. It will be interesting to see if political pressures, particularly in an election year in the U.S., impact this going forward.
- Grim Job Outlook for Retail Pharmacists, says BLS (drugchannels.net)
The New Year is here—let’s kick it off with some good news/bad news for pharmacists...According to our...analysis of the Bureau of Labor Statistics’ new Occupational Outlook Handbook, drugstores are projected to employ about 7,000 fewer pharmacists in 2024 than they do today...The good news? Pharmacists jobs in non-retail settings—hospitals, doctor’s office, and clinics—will add more jobs than the ones lost from retail...Employment will increase at other outpatient dispensing formats, with mail pharmacies experiencing the largest percentage increase..."Demand is projected to increase for pharmacists in a variety of healthcare settings, including hospitals and clinics. These facilities will need more pharmacists to oversee the medications given to patients and to provide patient care, performing tasks such as testing a patient’s blood sugar or cholesterol…Employment of pharmacists in traditional retail settings is projected to decline slightly as mail order and online pharmacy sales increase."
- Optimizing Relationships Among Manufacturers and Providers (specialtypharmacytimes.com)
David D'Altorio, PharmD, senior vice president of health services at MedImpact Healthcare Systems, discusses methods to improve communication among drug manufacturers and health care providers.
- Walgreens, CVS Want Doctors’ Medicare Pay To Vaccinate (forbes.com)Patient Access to Pharmacists’ Care Coalition (pharmacistscare.org)
As the nation’s retail pharmacies move deeper into the business of providing healthcare services, they now want pharmacists to be paid by Medicare to immunize the nation’s seniors....Under legislation that is gaining rare bipartisan support and momentum in the House and Senate, particularly for a Congressional health bill, pharmacists would be paid to administer vaccines under Medicare part B...The pharmacies have formed a coalition known as “The Patient Access to Pharmacists’ Care Coalition,” to push for the legislation, known as the Pharmacy and Medically Underserved Areas of Enhancement Act (S. 314/H.R. 592). The coalition includes retailers and grocery store chains with pharmacies such as Walgreens Boots Alliance , CVS Health, Wal-Mart, Kroger, Rite-Aid and Target...It could bring in hundreds of millions of dollars to the drugstore industry given the growing business of providing vaccinations.
- Maker of generic version of Nexium goes blue to settle litigation (statnews.com)
Dr. Reddy’s Laboratories is feeling blue over a purple pill...The generic drug maker last week agreed to change the color of its new version of the Nexium heartburn medicine from purple to blue in order to settle a lawsuit that was filed by AstraZeneca....For more than two decades, AstraZeneca has capitalized on a marketing campaign that labeled its two widely prescribed heartburn drugs — first, Prilosec and then Nexium — as “the Purple Pill.” But after Dr. Reddy’s last September began selling a lower-cost generic version, which resembled the brand-name drug, AstraZeneca claimed the Indian drug maker was ripping off its trademark look...