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At least one of President Trump's possible picks to head the Food and Drug Administration has a radical idea for when drugs should come to market...Jim O'Neill, managing director at Mithril Capital, has said that he is in favor of approving drugs that are proven to be safe, even before they're shown to be actually effective...Regardless of who Trump picks in the end, his interest in cutting regulation at the FDA is clear..."We're going to be cutting regulations at a level that nobody's ever seen before," Trump said in a meeting with pharma executives...As it exists right now, the FDA approval process can be a long and expensive…

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,"...

The Federal Trade Commission...accused a Shire plc subsidiary of filing dozens of "sham" petitions with the Food and Drug Administration in an effort to delay generic competition to its branded prescription drug Vancocin HCI...the FTC alleged that Shire ViroPharma filed 43 citizen petitions with the FDA (along with 3 lawsuits) over a seven-year period, knowing that the FDA typically waited to approve generic drugs until it had resolved any outstanding citizen petitions...a deliberate attempt to maintain a monopoly...ViroPharma’s efforts led consumers and other purchasers to pay hundreds of millions of dollars more for the drug.

Employers and drugmakers are eager to say good riddance to an excise tax on brand-name prescription medicines that could get stripped under the latest GOP plan to repeal ObamaCare...While the law’s other major taxes, like the medical device or so-called Cadillac taxes, generated major campaigns seeking their repeal, the prescription drug fee has garnered little publicity. But it’s no negligible element among the law's funding sources. It's expected to bring in $27 billion over a 10-year period, according to the Joint Committee on Taxation's 2010 estimates...But the branded pharmaceutical fee never attracted bipartisan backing for repeal and it went into effect in 2010...consumers are "insensitive to changes in the drug prices."...if someone needs a specialty drug that is likely to be a brand-name product, his or her insurance is going to pay for it or that person will have to pay out of pocket for that amount...if the price happens to go up, you’re still going to pay for the drug...The fight over repealing other ObamaCare taxes means it's still unclear whether the prescription fee will be gone in the first round of the health law’s repeal measures...there could be other opportunities to get rid of it. ObamaCare repeal is looking to be...a series of legislative actions and regulatory actions over the course of the next year or so...

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...

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).

As Sanofi and Regeneron scramble to keep their PCSK9 cholesterol drug Praluent on the market, Amgen’s rival drug Repatha already appears to be chipping away at its market share...For the week of January 20, Repatha’s prescription total hit 3,231, ahead of Praluent’s 2,859...The Praluent partners are of course embroiled in a patent fight against Amgen, which claims that Sanofi and Regeneron knowingly stepped on its patents in developing Praluent. A district court jury sided with Amgen, and the judge in the case granted Amgen’s request for an injunction that would push Praluent off the market...Sanofi and Regeneron hope that the threat is short-lived; they’re trying to persuade the U.S. Circuit Court of Appeals in Washington, D.C., to put off the injunction while their patent appeal is heard. In their request for a stay, the two companies argued that they have a good chance of winning their appeal and that pulling Praluent in the meantime would do great damage to Regeneron.

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...

After being blocked by a federal court, Aetna Inc. and Humana Inc. have decided to terminate their $37 billion merger deal...The health insurance giants said...that, with the move, Aetna will pay Humana a $1 billion breakup fee...In January...the...District Court for the District of Columbia ruled in favor of the Department of Justice’s request to enjoin the Aetna-Humana merger. The government claimed that the combination of the two health insurers would lessen competition, harming seniors who buy private Medicare coverage and some consumers who buy health insurance on public exchanges...The consolidation wave hitting the health insurance sector has been seen as a byproduct of the Affordable Care Act. The mega-deals would provide fast access to the millions of people who have gained health coverage under the ACA and would be a vehicle for capturing Medicaid business, which has expanded dramatically under the health reform law...the climate for mergers and acquisitions in the health care sector has become uncertain. Besides the DOJ’s opposition to the mega-mergers, the Trump administration and Republican leaders in Congress have begun efforts to dismantle the ACA. That has cast a cloud on the health insurance marketplace, since it remains unclear what would replace the ACA and how consumers who have obtained coverage via the exchanges would continue to receive benefits.

With hundreds of open positions and a slate of new initiatives to execute on at the FDA, President Donald Trump picked a particularly inconvenient time to declare a hiring freeze for the federal government...No one really knows how this is going to play out, but the speculation is rampant that the FDA will be forced to cut loose from its review timelines, which could have a big impact on a wide range of biopharma companies...the agency is expected to get a record 1600 ANDAs this year. Trump’s freeze could slow reviews on generics to a glacial pace, which in turn would interfere with the introduction of new discounted drugs that could go a long way to removing pressure on new drug prices...The only guarantee Trump can offer now is a rising level of uncertainty over the administration’s plans for the FDA. And that could take months to clarify during a particularly critical year for the biopharma industry...