Author: Peter

As the new Trump administration begins to take shape, there are concerns that new leadership at the FDA will call for less bureaucracy and red tape, thereby lowering the bar for new drug approvals. The view is that onerous regulations are preventing life-saving medications from getting to those who most need them. Lowering the standards for drug approvals may indeed allow for earlier patient access to drugs but...liberalization of current regulations would be a mistake. Such actions will unleash drugs that will ultimately prove to be ineffective and, in some cases, harmful rather than beneficial...the specter of deregulation, comes a call to increase the requirements for allowing early clinical trials of exploratory new medicines...Trials of ineffective therapies place burdens on society...Drug development soaks up financial and research resources...expenses wasted on ineffective therapies are often passed on to healthcare systems in the form of higher drug prices. The biopharmaceutical industry is testing “duds” and wasting precious resources because of unreasonable hope for a major commercial payoff...The biopharmaceutical industry is already heavily regulated. Current standards shouldn’t be lowered...

Instead of being gouged on the prices for old drugs, Americans could import certain meds from Canada if a bipartisan group of senators get their way...Sens. Klobuchar, Chuck Grassley, and John McCain...are pushing President Donald Trump’s new Department of Health and Human Services Secretary, Tom Price, to authorize cheap drug imports under strict circumstances...Their bill, the Safe and Affordable Drugs from Canada Act, would require the FDA to set up a “personal importation program” to allow individuals to import 90-day supplies of their meds from Canadian pharmacies...To qualify for importation, the senators' proposal would require products to be off patent or no longer marketed in the U.S. by the original developer. They'd need to be free of direct competition and to have seen a “significant, unexplained” price hike. The imported product would also need to be produced by a reputable company. The bill additionally calls for fast-track FDA reviews of competing drugs...Imported drugs wouldn’t “be subject to the U.S. Food and Drug Administration’s robust safety requirements, and there would be no way to trace the country of origin for the imported products...

Pharma has heard enough of New York Governor Andrew Cuomo’s ideas for lowering drug prices. Just a month after the governor unveiled his plan, the industry’s trade group is rolling out a counteroffensive urging state officials to “Prescribe Real Solutions”...Gov. Cuomo’s plan would create a board to rule on “fair prices” for certain expensive drugs. Then, the state would mandate that Medicaid refuse to pay more than that for those meds...Cuomo's proposal also factors into private market sales. If a pharma company sold into New York at a higher price than the board’s "fair price," the state would collect a surcharge...PhRMA is having none of that. The group’s Prescribe Real Solutions website asks the public to “demand real solutions” from their lawmakers...PhRMA’s deputy vice president for state advocacy in New York, maintains that Cuomo's proposal "does nothing to improve patient access to medicines, bring life-saving drugs to the market or create jobs" in the state..."This is not the time for unworkable proposals that would create new bureaucracies without actually addressing any of the factors that impact the prices paid by patients,"...

Pfizer and Flynn Pharma have appealed against the £89.4m ($111m) fine imposed by the UK Competition and Markets Authority (CMA) for charging excessive and unfair prices for an anti-epilepsy drug...Pfizer has been fined £84.2m($104m) and Flynn Pharma £5.2m ($6.4) after they increased prices by as much as 2,600% in September 2012...The companies have separately filed appeals in the Competition Appeal Tribunal...Both Pfizer and Flynn accused the UK watchdog of ignoring market realities when it ruled that the price Flynn paid to acquire the anti-epilepsy drug from Pfizer and the price it charged from the National Health Service (NHS) were both excessive...The CMA had stated that owing to the unreasonable price increase of the critical drug, the NHS’ annual expenditure to buy the phenytoin sodium capsules from Flynn had shot up to around £50m ($62m) in 2013 from the 2012 figure of £2m ($2.4).

It’s been in the air for much of the past year, and as many of the some-feared and some-promised changes have happened around us, those health care business owners who rely on insurance reimbursement have waited with bated breath for a sign of what’s to come. The Trump administration has promised, via stump speech and now executive order, the rapid repeal and replacement of the Affordable Care Act, but what is simple to say is often far more difficult to accomplish.

• MEDICARE UNSUSTAINABILITY... the U.S. population continues to age... This has contributed to explosive growth in Medicare participation...
• INSURING THE UNINSURED...the American public has determined to no longer accept 30 million uninsured Americans who are not Medicare-eligible as the status quo. Caring for these individuals through catastrophic care via public emergency rooms has become untenable both fiscally and morally…
• VALUE-BASED CARE...care reimbursement models have been established to replace the traditional fee-for-service model that has dominated American health care for generations. FFS models reimburse health care providers for services rendered in the form of treatment or testing and have seen unsustainable inflation over the past 10 years…
• ELECTRONIC HEALTH RECORDS...One of the key elements of a VBC system is the interoperability of health care records, which permits and encourages (by ease of use) coordination of care across providers...This reduces redundancies and the probability of contraindicated treatment being administered in good faith…
• ACCOUNTABLE CARE ORGANIZATIONS...are groups of health care providers who come together to voluntarily give coordinated high-quality care to their Medicare patients. ACOs tie payments to quality metrics and the cost of care…
• WHAT’S NEXT?...Increase capacity utilization...Consolidation…
• SCALING UP...While apparently antithetical to the current market, scaling up is the external version of increasing capacity utilization. Often a practice’s assets can only be maximized by increasing the scale of the practice...

A Genentech lobbyist who generated enormous sales for the company allegedly kept millions in consulting payments for himself and ended his own life after authorities and the company began looking into the charges...During his time lobbying for Roche and its Genentech unit, Evan Morris’ tactics boosted the company's top line by hundreds of millions of dollars, with the company's flu drug Tamiflu and cancer treatment Avastin among the products that benefited...Under investigation for embezzlement in July 2015, Morris committed suicide at a Virginia golf course...Morris’ lavish life, ...featured expensive houses, wines, influential contacts and more, before it came quickly crashing down. An obituary for Morris simply says he “resided in Alexandria, VA.” He was born in 1977 and died on July 9, 2015, the obituary says.

In a hotly anticipated judgment, the U.S. patent office...ruled that key patents held by the Broad Institute of MIT and Harvard on the gene-editing technology CRISPR-Cas9 do not overlap with competing claims from the University of California...UC may now receive a patent covering broader claims on the revolutionary tech...the Patent Trial and Appeal Board ruled the claims of UC and the Broad to be patentably distinct subject matter, leading the three judges to declare a judgment of non-interference...Put into layman's terms, the claims of the UC and the Broad are distinct enough so as to be separately patentable and therefore don't overlap with each other. This effectively supports the Broad's existing patents, while sending the UC's pending patent application back to the initial patent examiner...UC with a patent on use of CRISPR in all cells and the Broad with a patent for use of CRISPR specifically in eukaryotic cells...If that were to happen, biotechs operating in the space could end up having to license the tech from both UC and the Broad.

Researchers at Eindhoven University of Technology present a new method that should enable controlled drug delivery into the bloodstream using DNA computers. In the journal Nature Communications the team...describes how it has developed the first DNA computer capable of detecting several antibodies in the blood and performing subsequent calculations based on this input. This is an important step towards the development of smart, 'intelligent' drugs that may allow better control of the medication for rheumatism and Crohn's disease, for example, with fewer side-effects and at lower cost...An analogy for the method presented…is a security system that opens the door depending on the person standing in front of it. If the camera recognizes the person, the door unlocks, but if the person is unknown, the door remains locked. "Research into diagnostic tests tends to focus on the 'recognition', but what is special about this system is that it can think and that it can be connected to actuation such as drug delivery...

President Donald Trump's vow to roll back government regulations at least 75 percent is causing anxiety for some pharmaceutical executives that a less robust Food and Drug Administration would make it harder to secure insurance coverage for pricey new medicines...Industry trade group Biotechnology Innovation Organization told Reuters...lobbyists urged the administration not to name a new commissioner of the Food and Drug Administration who would act rashly to speed up the agency’s approval of new medicines...the FDA is already adopting new drug development models and warned that a looser review process would put patients at risk...People often argue that the FDA is too restrictive...We have the sense that the balance is pretty right...you have to have a well-characterized risk/benefit profile."...While most sectors welcome less oversight, drugmakers say a robust review process is critical in convincing physicians and insurers that a pricey new medicine has value...Otherwise, the time and money it takes to get a new drug to market - estimates run as high as $2.6 billion - would be lost if insurers are not willing to pay for the product... payers are looking for evidence of value...

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network