- Drug shortages loom from hurricane-impaired manufacturing in Puerto Rico (pharmacist.com)
Damaged Baxter plants on the island make large portion of saline products, already in short supply...hospitals are feeling even more compromised from the shortage ever since production at Baxter facilities in Puerto Rico was hampered...by hurricane Maria...“Clearly this has a huge impact on hospitals as well as home infusion pharmacies and infusion centers since many medications given by the I.V. route are mixed into these bags and given by infusion,” said Matthew Grissinger, RPh, from the Institute for Safe Medication Practices...The most severe shortages are being felt with small-volume parenteral solutions, such as the 50 and 100 milliliter minibags of sodium chloride 0.9%, dextrose 5%, and I.V. nutritional products made by Baxter...the American Society of Health-System Pharmacists had been hearing from both large and small hospitals alike that they only had a 1- to 2-week supply of small-volume parenteral solutions left. ASHP has been working around the clock to identify solutions and strategies for facilities...FDA has also been actively involved, and is monitoring a list of about 30 critical drug products that are either manufactured solely or primarily in Puerto Rico. Of those 30 drugs, 14 are sole-source products, meaning there are no alternatives available...To mitigate the shortage of I.V. solution products, FDA is doing something that it rarely does: import products from overseas plants. In this case, FDA is allowing temporary importation of an alternative supply of sodium chloride 0.9% injection bags, dextrose 5% injection bags, and metronidazole injection into the U.S. from Baxter facilities in Ireland, Australia, Mexico, and Canada...
- How Doctors Are Getting Rich on Urine Tests for Opioid Patients (bloomberg.com)
Want to turn that pain clinic into a real moneymaker? Open your own urine-testing lab and start billing Medicare...The cups of urine travel by express mail to the Comprehensive Pain Specialists lab in an industrial park in Brentwood, Tennessee...Most days bring more than 700 of the little sealed cups from clinics across 10 states, wrapped in red-tagged waste bags...The high-tech testing lab’s raw material has become liquid gold for the doctors who own Comprehensive Pain Specialists. This testing process, driven by the nation’s epidemic of painkiller addiction, generates profits across the doctor-owned network of 54 clinics, the largest pain-treatment practice in the Southeast. Medicare paid the company at least $11 million for urine and related tests in 2014...the costly tests are medically justified to monitor patients on pain pills against risks of addiction or even of selling pills on the black market. “I have to know the medicine is safe and you’re taking it,”...As alarm spread about opioid deaths and overdoses in the past decade, doctors who prescribed the pills were looking for ways to prevent abuse and avert liability. Entrepreneurs saw a lucrative business model: persuade doctors that testing would keep them out of trouble with licensing boards or law enforcement and protect their patients from harm. Some companies offered doctors technical help opening up their own labs...“drug testing is not about medicine but about making money, and I am going to show you how to make a lot of money.”...
- CEO of Botox maker Allergan on Mohawk tribe patent deal: ‘It wasn’t desperation, it was tenacity’ (cnbc.com)Senators blast Allergan's tribal deal, social contract as 'hypocrisy' (fiercepharma.com)Allergan executives named in investor suit over alleged generics price fixing (fiercepharma.com)
"Mad Money" host Jim Cramer and Allergan CEO Brent Saunders discussed the biopharmaceutical company's prospects...Allergan's unusual patent deal with a Native American tribe was misunderstood by Wall Street...Allergan's controversial deal with the Saint Regis Mohawk tribe giving the group the patent rights to one of its key drugs was widely misunderstood..."It wasn't desperation, it was tenacity."...In exchange for the patents for Allergan's eye drug, Restasis, and $13.75 million (plus potentially $15 million in annual royalties), the tribe granted Allergan an exclusive license to sell the drug...The deal involving the billion-dollar drug drew widespread criticism, raising concerns that Allergan could now raise the price of Restasis while keeping it under patent protection...Saunders acknowledged big pharma's duty to patients and consumers..."The flip side of that is I have a social contract that says when we are successful, we'll price it responsibly and we'll make them accessible to those people who can't afford them,"..."And I think people got confused that said because I believe in strong intellectual property, I don't believe in making medicines affordable and accessible, and one has nothing to do with the other."
- Connecticut AG on generic drug price-fixing suit: ‘This is just the tip of the iceberg’ (cnbc.com)
Connecticut Attorney General George Jepsen, who is leading a coalition of states suing generic drugmakers, told CNBC..."We've uncovered through emails, text messages and telephone patterns, plus cooperating witnesses, a very compelling case of systematic and pervasive price fixing within the industry,"...45 states, including Connecticut, as well as the District of Columbia and Puerto Rico moved to expand their lawsuit to 18 companies and 15 medicines. The suit also names two individual executives, including Rajiv Malik, president (of)...Mylan...The original complaint, filed in December, had focused on six companies and two medicines...
- Drug bingo: EU readies vote for London-based pharma agency (reuters.com)'Hard' Brexit risks disrupting supply of thousands of drugs (biopharmadive.com)
Nineteen EU governments will slug it out in a series of secret ballots in 10 days’ time for the right to host the European Medicines Agency once it leaves London after Brexit...Confirming that none of the cities, from Porto to Helsinki, has dropped out of the running...those organizing it confessed they had no idea how long the voting would take...The EMA itself has warned that moving to some of the cities on the list -- sources have said notably those like Warsaw or Sofia in eastern Europe -- would see so many of its 900 London staff quit that it would harm Europe’s health. Top choices for employees are Amsterdam, Vienna and Barcelona...States agreed to a number of criteria, including that cities chosen should offer premises ready for a start in March 2019, when Britain leaves the EU, be accessible from across Europe and take account of “geographical spread” -- the fact newer members in the east host fewer agencies than richer neighbors.
- FDA commissioner warns drug companies of ‘disruptive’ regulations to fight opioid epidemic (cnbc.com)
The Food and Drug Administration is likely to take new actions on opioids that may be "disruptive" and "uncomfortable" to drugmakers, the agency's commissioner (Scott Gottlieb) said...In addition to seeking to treat opioid-addicted patients with alternative medications that don't produce a high, the FDA says it will look at ways to reduce exposure to the drug. That includes new ways of packaging and distribution..."For example, it's possible that a defined, short-term supply of medication could be packaged in a manner that limits the number of pills dispensed,"..."We're at a point in this crisis that we're going to have to think of ideas and taking actions that are going to be more disruptive and are going to be uncomfortable to some parties," Gottlieb told "Squawk Box." "But we have to take more vigorous action to get ahead of this."...Gottlieb said the agency is having discussions with drug companies about the new packaging solutions..."Something like this could move potentially quickly," he said. "We're invested in taking a hard look at this and seeing what the opportunities are."...
- Ohio Ballot Issue 2: Cap State Agency Drug Costs (nytimes.com)Handing pharma a win, Ohio voters overwhelmingly reject drug pricing measure (fiercepharma.com)
An initiative on Tuesday’s ballot in Ohio is aimed at reducing the cost of prescription drugs in the state. The measure would cap the price of prescription drugs purchased by the state government, including Medicaid...The measure drew strong resistance from drug makers, which spent more than $49 million to try to kill it, and the industry is not accustomed to losing political fights. Last year, it successfully killed a measure in California that was similar to the one in Ohio, but only after spending more than $100 million to do so.
- U.S. states allege broad generic drug price-fixing collusion (reuters.com)
A large group of U.S. states accused key players in the generic drug industry of a broad price-fixing conspiracy, moving...to widen an earlier lawsuit to add many more drugmakers and medicines in an action that sent some company shares tumbling...The lawsuit, brought by the attorneys general of 45 states and the District of Columbia, accused 18 companies and subsidiaries and named 15 medicines. It also targeted two individual executives: Rajiv Malik, president and executive director of Mylan NV, and Satish Mehta, CEO and managing director of India’s Emcure Pharmaceuticals...The states said the drugmakers and executives divided customers for their drugs among themselves, agreeing that each company would have a certain percentage of the market. The companies sometimes agreed on price increases in advance...“It is our belief that price-fixing is systematic, it is pervasive, and that a culture of collusion exists in the industry,” Connecticut Attorney General George Jepsen, who is leading the case...The...Justice Department is conducting a parallel criminal investigation. On Friday, the department asked the Pennsylvania court presiding over the lawsuit to put the lawsuit’s discovery process on hold, saying it could interfere with the criminal probe
- U.S. drug pricing watchdog gets funding to expand efforts (reuters.com)
The...Institute for Clinical and Economic Review (ICER) announced a three-year, $13.9 million grant from the Laura and John Arnold Foundation, which follows its initial two-year $5.2 million award from the foundation in 2015...ICER has previously issued reports outlining what it believes to be an appropriate cost for new medicines to treat high cholesterol, lung cancer, hepatitis C and other conditions, typically suggesting a value to patients that is a fraction of prices set by drugmakers...The new funding will enable ICER to evaluate all newly approved medicines, rather than select high profile drugs...Pharmacy benefit managers, insurers and government agencies have all used ICER reports in negotiating pricing and preferred formulary placements with manufacturers, ICER President Steven Pearson said in an interview, mentioning Express Scripts, CVS Health, the U.S. Department of Veterans Affairs and others...Rather than working from list prices as it did initially, ICER now attempts to “come up with a more precise estimate incorporating average net prices, taking rebates into account, to determine what it considers fair value-based pricing,” Pearson said...“We want to come up with an approach at ... determining when price increases are or aren’t justified,”...
- Potential CVS-Aetna merger: Top 6 industry implications (managedhealthcareexecutive.modernmedicine.com)
- The way could be paved for other new healthcare models...“Payers should pay close attention to the integration of pharmacy, retail, care management, and patient care that could be possible under a combined company,”...While being early to a merger like this could bode well for CVS-Aetna, it could also give other payers the roadmap they need to explore similar mergers, or scope similar partnerships without the full-scale merging of two companies...
- Intermediaries, which were intended to be the impartial arbiters, now have the ability to control markets on the demand (i.e., formulary) and the supply (i.e., provider networks, their own providers)...“While this has been a concern with the PBM industry for years, it is significantly exacerbated when the overall medical carrier is also the PBM,”...“Economically, why this is more significant is that unlike medical provider systems which have geographic diversity, making it difficult if not impossible to consolidate them, pharmacy chains have little diversity and are already organized into national chains...making it possible to buy and require the usage of their own chain, thereby controlling both what product is purchased, the price, and the supplier.”
- These complex mergers are new categories—neither payer nor provider—for which existing laws are insufficient to regulate...“It is almost impossible for a buyer to understand what they are buying, and in contracting, who is selling what,”...“Every deal now is a complex web of contracts, intermediaries, and providers. It is becoming harder and harder to understand the economics of what services are being purchased and how that compares to other alternatives, especially on the ‘vertically integrated bundles’ that are becoming the norm...
- Big data analytics technology will be front and center...“Big data will become even more important for private and government plans to more effectively coordinate and manage internally owned means of production,”..
- There will be increased negotiating power on large market drugs and fewer mouths to feed in the value chain...“Specialty higher priced drugs will likely not be too affected by the merger, but certainly larger market drugs are going to have potentially big players pushing hard on price and value to patients to drive share...”
- Patients might win—or lose...“The merger likely would lower prices and improve access, which is beneficial for both the pharmaceutical industry and patients,”...