The last three months have been good ones for investors in the pharmaceutical and biotech markets and with a new year upon us, some analysts are already picking potential winners in the market for 2020. One of those companies could be Denmark-based Novo Nordisk.
Over the last 12 months, shares of the Danish drugmaker have steadily increased by 24% to today’s price of $57.68, as of 10:04 a.m. Novo Nordisk is one of the biggest manufacturers of diabetes drugs and insulin in the world. While insulin manufacturers, including Eli Lilly and Sanofi, are under fire by lawmakers in the United States due to the high prices, one analyst has pegged the company as a buy in 2020, especially with the approval of Rybelsus, an oral-semaglutide. In September, the U.S. Food and Drug Administration approved Rybelsus, a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist, approved for type 2 diabetes. Writing in The Motley Fool, analyst Prosper Junior Bakiny said “the addressable market” for Rybelsus “makes its prospects mouth-watering.”
The FDA is continuing to review Rybelsus for another indication to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. Novo Nordisk said it anticipates a decision on that indication in the first quarter of 2020.
“Thus, sales of Novo Nordisk’s GLP-1 drugs will likely continue leading its revenue on an upward trajectory, and the company’s shares could continue climbing in 2020,” Bakiny said after rating the company a “buy” for 2020.
Not only did the FDA approve Rybelsus, in October, the regulatory agency also expanded the label for Novo Nordisk’s Fiasp (insulin aspart injection) to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes. Fiasp, a rapid-acting insulin, was first approved by the FDA in 2017 for use by intravenous infusion under supervision by a healthcare professional or by subcutaneous multiple daily injections in adults with diabetes.
In addition to the approval of Rybelsus and the expanded label for Fiasp. Novo Nordisk has spent the past several months forging collaborations with various companies as it looks to expand its pipeline in new directions. In October, the company entered into an R&D deal with bluebird bio to develop next-generation genome editing therapies for genetic diseases, including hemophilia. The initial focus of the three-year deal will be on correcting FVIII-clotting factor deficiency. Then, in November, Novo Nordisk partnered with Dicerna Pharmaceuticals to discover and develop therapies for liver-related cardio-metabolic diseases. The two companies will leverage Dicerna’s GalXC RNAi technology platform to explore more than 30 liver cell targets. The indications for the R&D pact are broad, including chronic liver disease, non-alcoholic steatohepatitis, type 2 diabetes, obesity, and rare diseases.
Acceleron Pharma and Fulcrum Therapeutics are entering 2020 as partners to tackle pulmonary diseases. On Monday, the two companies forged a collaboration and license agreement that has the potential to be worth more than $450 million.
The Cambridge, Mass.-based companies inked a deal to identify small molecules designed to modulate specific pathways associated with a targeted indication within the pulmonary disease space. Fulcrum has a product engine and target identification platform that uses computational biology, as well as a proprietary relational database that will help in the identification of small molecules that control the expression of certain genes. Acceleron will use Fulcrum’s platform to focus on genes that are known to impact specific pathways associated with pulmonary disease, the companies said. Fulcrum has also used the platform for drug discovery in a range of genetically defined muscle, central nervous system and blood disorders. Acceleron will be responsible for all development and commercialization activities for any potential therapeutics identified via this platform.
Habib Dable, chief executive officer of Acceleron, said the collaboration brings in Fulcrum’s skill in identifying drug targets that are based on the modulation of genetic pathways associated with disease. That knowledge, Dable said, will be paired with Acceleron’s “deep expertise in TGF-beta superfamily signaling.” The different skill sets the companies bring together will be aimed at generating what they hope will become disease-modifying therapies.
For Acceleron, the deal comes several months after its mid-stage asset sotatercept received Orphan Drug Designation from the U.S. Food and Drug Administration as a potential treatment in pulmonary arterial hypertension (PAH). Sotatercept is being evaluated in two Phase II trials in patients with PAH, with top-line results from one of those trials expected in the first quarter of 2020. Sotatercept is an investigational agent designed to be a selective ligand trap for members of the TGF-beta superfamily to rebalance BMPR2 signaling, which is a key molecular driver of PAH, a rare progressive disorder that is characterized by the constriction of pulmonary arteries and elevated blood pressure in the pulmonary circulation.
“With this agreement, along with the advancement of the Acceleron-discovered assets sotatercept—in Phase II trials in pulmonary arterial hypertension—and ACE-1334, we underscore our growing commitment to the development of novel therapies for patients with pulmonary diseases of high unmet medical need,” Dable said in a statement.
Under terms of the agreement, Acceleron will provide Fulcrum with an upfront payment of $10 million and will reimburse the company for relevant R&D costs. Fulcrum will also R&D and commercial milestone payments of up to $295 million for the first product to be approved as a result of this collaboration. Also, Fulcrum will receive up to $143.5 million in additional milestone payments for all subsequent products commercialized, the companies said.
Fulcrum CEO Robert J. Gould said the collaboration with Acceleron builds on the “proven potential” of the company’s platform to identify therapies that can address the root cause of diseases. He noted that the platform led to the discovery of Fulcrum’s mid-stage asset losmapimod, an investigational treatment for facioscapulohumeral muscular dystrophy (FSHD) in patients with a genetically confirmed diagnosis of FSHD.
“This new opportunity to screen and identify pulmonary disease-specific therapies is another reflection of the broad potential applications of the Fulcrum platform in gene modulation,” Gould said in a statement.
“There’s nothing that I’ve seen in my 30-plus years studying medicine that could be as impactful and transformative” as AI, said Dr. Eric Topol, a cardiologist and executive vice president of Scripps Research in La Jolla, Calif. AI can help doctors interpret MRIs of the heart, CT scans of the head and photographs of the back of the eye, and could potentially take over many mundane medical chores, freeing doctors to spend more time talking to patients, Topol said.
Early experiments in AI provide a reason for caution, said Mildred Cho, a professor of pediatrics at Stanford’s Center for Biomedical Ethics.
Systems developed in one hospital often flop when deployed in a different facility, Cho said. Software used in the care of millions of Americans has been shown to discriminate against minorities. And AI systems sometimes learn to make predictions based on factors that have less to do with disease than the brand of MRI machine used, the time a blood test is taken or whether a patient was visited by a chaplain. In one case, AI software incorrectly concluded that people with pneumonia were less likely to die if they had asthma ― an error that could have led doctors to deprive asthma patients of the extra care they need.
“It’s only a matter of time before something like this leads to a serious health problem,” said Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic.
Medical AI, which pulled in $1.6 billion in venture capital funding in the third quarter alone, is “nearly at the peak of inflated expectations,” concluded a July report from the research company Gartner. “As the reality gets tested, there will likely be a rough slide into the trough of disillusionment.”
That reality check could come in the form of disappointing results when AI products are ushered into the real world. Even Topol, the author of “Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again,” acknowledges that many AI products are little more than hot air. “It’s a mixed bag,” he said.
Experts such as Dr. Bob Kocher, a partner at the venture capital firm Venrock, are blunter. “Most AI products have little evidence to support them,” Kocher said. Some risks won’t become apparent until an AI system has been used by large numbers of patients. “We’re going to keep discovering a whole bunch of risks and unintended consequences of using AI on medical data,” Kocher said.
None of the AI products sold in the U.S. have been tested in randomized clinical trials, the strongest source of medical evidence, Topol said. The first and only randomized trial of an AI system ― which found that colonoscopy with computer-aided diagnosis found more small polyps than standard colonoscopy ― was published online in October.
Few tech startups publish their research in peer-reviewed journals, which allow other scientists to scrutinize their work, according to a January article in the European Journal of Clinical Investigation. Such “stealth research” ― described only in press releases or promotional events ― often overstates a company’s accomplishments.
And although software developers may boast about the accuracy of their AI devices, experts note that AI models are mostly tested on computers, not in hospitals or other medical facilities. Using unproven software “may make patients into unwitting guinea pigs,” said Dr. Ron Li, medical informatics director for AI clinical integration at Stanford Health Care.
AI systems that learn to recognize patterns in data are often described as “black boxes” because even their developers don’t know how they have reached their conclusions. Given that AI is so new ― and many of its risks unknown ― the field needs careful oversight, said Pilar Ossorio, a professor of law and bioethics at the University of Wisconsin-Madison.
Yet the majority of AI devices don’t require FDA approval.
“None of the companies that I have invested in are covered by the FDA regulations,” Kocher said.
Legislation passed by Congress in 2016 ― and championed by the tech industry ― exempts many types of medical software from federal review, including certain fitness apps, electronic health records and tools that help doctors make medical decisions.
There’s been little research on whether the 320,000 medical apps now in use actually improve health, according to a report on AI published Dec. 17 by the National Academy of Medicine.
If failing fast means a whole bunch of people will die, I don’t think we want to fail fast. Nobody is going to be happy, including investors, if people die or are severely hurt.
“Almost none of the [AI] stuff marketed to patients really works,” said Dr. Ezekiel Emanuel, professor of medical ethics and health policy in the Perelman School of Medicine at the University of Pennsylvania.
The FDA has long focused its attention on devices that pose the greatest threat to patients. And consumer advocates acknowledge that some devices ― such as ones that help people count their daily steps ― need less scrutiny than ones that diagnose or treat disease.
Industry analysts say that AI developers have little interest in conducting expensive and time-consuming trials. “It’s not the main concern of these firms to submit themselves to rigorous evaluation that would be published in a peer-reviewed journal,” said Joachim Roski, a principal at Booz Allen Hamilton, a technology consulting firm, and co-author of the National Academy’s report. “That’s not how the U.S. economy works.”
But Oren Etzioni, chief executive officer at the Allen Institute for AI in Seattle, said AI developers have a financial incentive to make sure their medical products are safe.
“If failing fast means a whole bunch of people will die, I don’t think we want to fail fast,” Etzioni said. “Nobody is going to be happy, including investors, if people die or are severely hurt.”
Many of these devices were cleared for use through a controversial process called the 510(k) pathway, which allows companies to market “moderate-risk” products with no clinical testing as long as they’re deemed similar to existing devices.
In 2011, a committee of the National Academy of Medicine concluded the 510(k) process is so fundamentally flawed that the FDA should throw it out and start over.
Instead, the FDA is using the process to greenlight AI devices.
Of the 14 AI products authorized by the FDA in 2017 and 2018, 11 were cleared through the 510(k) process, according to a November article in JAMA. None of these appear to have had new clinical testing, the study said. The FDA cleared an AI device designed to help diagnose liver and lung cancer in 2018 based on its similarity to imaging software approved 20 years earlier. That software had itself been cleared because it was deemed “substantially equivalent” to products marketed before 1976.
AI products cleared by the FDA today are largely “locked,” so that their calculations and results will not change after they enter the market, said Bakul Patel, director for digital health at the FDA’s Center for Devices and Radiological Health. The FDA has not yet authorized “unlocked” AI devices, whose results could vary from month to month in ways that developers cannot predict.
To deal with the flood of AI products, the FDA is testing a radically different approach to digital device regulation, focusing on evaluating companies, not products.
The FDA’s pilot “pre-certification” program, launched in 2017, is designed to “reduce the time and cost of market entry for software developers,” imposing the “least burdensome” system possible. FDA officials say they want to keep pace with AI software developers, who update their products much more frequently than makers of traditional devices, such as X-ray machines.
Scott Gottlieb said in 2017 while he was FDA commissioner that government regulators need to make sure its approach to innovative products “is efficient and that it fosters, not impedes, innovation.”
Under the plan, the FDA would pre-certify companies that “demonstrate a culture of quality and organizational excellence,” which would allow them to provide less upfront data about devices.
Pre-certified companies could then release devices with a “streamlined” review ― or no FDA review at all. Once products are on the market, companies will be responsible for monitoring their own products’ safety and reporting back to the FDA. Nine companies have been selected for the pilot: Apple, FitBit, Samsung, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Tidepool and Verily Life Sciences.
High-risk products, such as software used in pacemakers, will still get a comprehensive FDA evaluation. “We definitely don’t want patients to be hurt,” said Patel, who noted that devices cleared through pre-certification can be recalled if needed. “There are a lot of guardrails still in place.”
But research shows that even low- and moderate-risk devices have been recalled due to serious risks to patients, said Diana Zuckerman, president of the National Center for Health Research. “People could be harmed because something wasn’t required to be proven accurate or safe before it is widely used.”
In a series of letters to the FDA, the American Medical Association and others have questioned the wisdom of allowing companies to monitor their own performance and product safety.
“The honor system is not a regulatory regime,” said Dr. Jesse Ehrenfeld, who chairs the physician group’s board of trustees.
In an October letter to the FDA, Sens. Elizabeth Warren (D-Mass.), Tina Smith (D-Minn.) and Patty Murray (D-Wash.) questioned the agency’s ability to ensure company safety reports are “accurate, timely and based on all available information.”
When Good Algorithms Go Bad
Some AI devices are more carefully tested than others.
An AI-powered screening tool for diabetic eye disease was studied in 900 patients at 10 primary care offices before being approved in 2018. The manufacturer, IDx Technologies, worked with the FDA for eight years to get the product right, said Dr. Michael Abramoff, the company’s founder and executive chairman.
The test, sold as IDx-DR, screens patients for diabetic retinopathy, a leading cause of blindness, and refers high-risk patients to eye specialists, who make a definitive diagnosis.
IDx-DR is the first “autonomous” AI product ― one that can make a screening decision without a doctor. The company is now installing it in primary care clinics and grocery stores, where it can be operated by employees with a high school diploma. Abramoff’s company has taken the unusual step of buying liability insurance to cover any patient injuries.
Yet some AI-based innovations intended to improve care have had the opposite effect.
A Canadian company, for example, developed AI software to predict a person’s risk of Alzheimer’s based on their speech. Predictions were more accurate for some patients than others. “Difficulty finding the right word may be due to unfamiliarity with English, rather than to cognitive impairment,” said co-author Frank Rudzicz, an associate professor of computer science at the University of Toronto.
Doctors at New York’s Mount Sinai Hospital hoped AI could help them use chest X-rays to predict which patients were at high risk of pneumonia. Although the system made accurate predictions from X-rays shot at Mount Sinai, the technology flopped when tested on images taken at other hospitals. Eventually, researchers realized the computer had merely learned to tell the difference between that hospital’s portable chest X-rays ― taken at a patient’s bedside ― with those taken in the radiology department. Doctors tend to use portable chest X-rays for patients too sick to leave their room, so it’s not surprising that these patients had a greater risk of lung infection.
While it is the job of entrepreneurs to think big and take risks, it is the job of doctors to protect their patients.
DeepMind, a company owned by Google, has created an AI-based mobile app that can predict which hospitalized patients will develop acute kidney failure up to 48 hours in advance. A blog post on the DeepMind website described the system, used at a London hospital, as a “game changer.” But the AI system also produced two false alarms for every correct result, according to a July study in Nature. That may explain why patients’ kidney function didn’t improve, said Dr. Saurabh Jha, associate professor of radiology at the Hospital of the University of Pennsylvania. Any benefit from early detection of serious kidney problems may have been diluted by a high rate of “overdiagnosis,” in which the AI system flagged borderline kidney issues that didn’t need treatment, Jha said. Google had no comment in response to Jha’s conclusions.
False positives can harm patients by prompting doctors to order unnecessary tests or withhold recommended treatments, Jha said. For example, a doctor worried about a patient’s kidneys might stop prescribing ibuprofen ― a generally safe pain reliever that poses a small risk to kidney function ― in favor of an opioid, which carries a serious risk of addiction.
As these studies show, software with impressive results in a computer lab can founder when tested in real time, Stanford’s Cho said. That’s because diseases are more complex ― and the health care system far more dysfunctional ― than many computer scientists anticipate.
Many AI developers cull electronic health records because they hold huge amounts of detailed data, Cho said. But those developers often aren’t aware that they’re building atop a deeply broken system. Electronic health records were developed for billing, not patient care, and are filled with mistakes or missing data.
A KHN investigation published in March found sometimes life-threatening errors in patients’ medication lists, lab tests and allergies.
In view of the risks involved, doctors need to step in to protect their patients’ interests, said Dr. Vikas Saini, a cardiologist and president of the nonprofit Lown Institute, which advocates for wider access to health care.
“While it is the job of entrepreneurs to think big and take risks,” Saini said, “it is the job of doctors to protect their patients.”
PARTNERS HEALTHCARE is moving to eliminate surprise billing, where consumers receive large, unexpected hospital bills after unknowingly being treated by a doctor who doesn’t accept their insurance.
The Partners policy on surprise billing surfaced during a CommonWealth Codcast interview with Lora Pellegrini, president and CEO of the Massachusetts Association of Health Plans.
“Partners has told me they are going to stop this practice,” she said. “The physicians will be either employed or contracted through Partners. That’s an important example for all other providers in this state.”
A Partners spokesman, Rich Copp, confirmed that the state’s largest hospital system is moving to eliminate surprise billing. “That’s our goal and we’re moving toward it,” he said.
Pellegrini, interviewed by the Health or Consequences hosts John McDonough of Harvard’s T.H. Chan School of Public Health and Paul Hattis of Tufts University Medical School, talked about a wide range of issues, including rising pharmaceutical costs, the shift toward primary and behavioral health care, the disparity in hospital pricing, and Sen. Elizabeth Warren’s “scary” conversion to Medicare for All.
Perhaps the newsiest element of the discussion centered on so-called facility fees and surprise out-of-network charges.
Pellegrini said hospital facility fees started out as charges assessed when patients visited an office on a hospital campus that contributes to the campus’s overhead costs for such things as parking and security. She said the fees, often in the $400 to $500 range, are now being collected by facilities that have little or no connection to the hospital.
“There’s really no reason for that,” Pellegrini said, noting the insurers that belong to her organization favor a ban on facility fees.
Pellegrini said she was the victim of surprise billing this past summer. She went in for a procedure after making sure her doctor and the hospital were part of her insurance network. She said she wondered about the anesthesiologist handling her case, but decided not to ask him his affiliation.
“I wanted him to wake me up at the end of the procedure so I didn’t ask anything,” she said.
She ended up with a $1,600 bill that she wasn’t expecting. “It was blinded to me,” she said.
There have been lots of stories about Americans getting hit with unexpected bills when they go to a hospital that accepts their insurance but get treated somewhere along the way by an out-of-network physician who doesn’t. Pellegrini said the out-of-network physicians are typically anesthesiologists, radiologists, emergency room doctors, and pathologists.
Earlier this month, Congress seemed poised to address the problem in a massive end-of-year spending bill. Democrats, Republicans, and President Trump were all on board with banning surprise billing, spurred on by strong public support and anecdotal evidence of unfairness. The sticking point was how insurers should compensate the out-of-network physicians. Some favored payments based on the median of what insurers in the area pay their in-network physicians. Others wanted the insurer and the out-of-network physician to let an arbitrator set the rate. Congressional negotiators settled on a blend of the two approaches – median rates for all bills with the proviso that charges greater than $750 could go to arbitration.
At the last minute, however, the House Ways and Means Committee, led by Rep. Richard Neal of Springfield, issued a vaguely worded one-page proposal that signaled a divide in Congress on the issue and the measure failed to make it into the spending bill.
Neal has come under fire for his role in the legislation’s demise after accepting $26,200 in donations from eight executives at the Blackstone Group, according to Federal Election Commission data. Blackstone is a private equity firm that owns Team Health, a physician staffing firm. Blackstone officials ranked second among Neal’s five top donors in the current election cycle, according to the website Open Secrets.
(Overall, Blackstone has donated $897,030 to members of Congress this election cycle, with Neal receiving the 11th highest amount, behind Sens. Ed Markey ($30,000), Susan Collins ($63,800), and Mitch McConnell ($78,200).
Neal said his concern with the surprise billing legislation was with how quickly the compromise was being pushed through Congress. His political challenger, Holyoke Mayor Alex Morse, saw it differently. “It’s evident who Congressman Neal is working for. He’s certainly not working for the people,” he said.
Pellegrini said the Massachusetts Legislature may take up surprise billing, but warned that the issue of how to compensate out-of-network physicians is likely to arise on Beacon Hill as well. She said her organization favors paying the out-of-network physician some benchmark rate based on what insurers are paying in the area or some multiple of what Medicare pays. She said the state’s health insurers oppose arbitration.
“We have heard from the providers that they want to hold the patient harmless, but that there should be a negotiation between the health plans and the provider,” she said. “I want to say to your listeners, if the plans don’t prevail, then these additional costs end up in your premium. So I think we want to set a reasonable rate.”
Roche’s Tecentriq was rejected by the U.K.’s health-cost overseer for treatment of late-stage lung cancer.
Adding the Roche drug to conventional treatments doesn’t meet standards for cost-effectiveness, the National Institute for Health and Care Excellence said in draft guidance published on its website. The agency estimates the average cost of a course of lung cancer treatment with Tecentriq at about 32,800 pounds ($43,100).
Approved by U.S. and European regulators, Tecentriq is one of a group of immune system stimulating drugs that are battling for ascendancy in the treatment of lung cancer, the world’s most common and deadly tumor. While the addition of Tecentriq to standard therapy extends patient survival, it’s not considered a cost-effective use of the national health system’s resources, NICE said.
England’s National Health Service, which offers care to all citizens, has tried to control spending through tough negotiations with drugmakers. Roche Chief Executive Officer Severin Schwan has slammed the U.K. drug watchdog for its approach to evaluation, saying that it discourages innovation and needs to be overhauled.
NICE will issue its final guidance on Tecentriq after considering comments from the public. An appraisal committee meeting is scheduled for Feb. 18.
Drugmakers including Pfizer Inc, GlaxoSmithKline PLC and Sanofi are planning to hike U.S. list prices on more than 200 drugs in the United States on Wednesday, according to drugmakers and data analyzed by healthcare research firm 3 Axis Advisors.
Nearly all of the price increases will be below 10%, and around half of them are in the range of 4 to 6%, said 3 Axis co-founder Eric Pachman. The median price increase is around 5%, he said.
More price increases are expected to be announced later this week, which could affect the median and range.
Soaring U.S. prescription drug prices are expected to again be a central issue in the presidential election. President Donald Trump, who made bringing them down a core pledge of his 2016 campaign, is running for re-election in 2020.
Many branded drugmakers have pledged to keep their U.S. list price increases below 10% a year, under pressure from politicians and patients.
Drugmakers often negotiate rebates on their list prices in exchange for favorable treatment from healthcare payers. As a result, health insurers and patients rarely pay the full list price of a drug.
Pfizer will hike prices on more than 50 drugs, including its cancer treatment Ibrance, which is on track to bring in nearly $5 billion in revenue this year, and rheumatoid arthritis drug Xeljanz.
Pfizer spokeswoman Amy Rose confirmed the company’s planned price increases. She said the company plans to increase the list prices on around 27% of its portfolio in the United States by an average of 5.6%.
Of the medicines with increases, she said 43% of them are sterile injectibles, and many of those increases are less than $1 per product.
GlaxoSmithKline said it will raise prices on more than 30 drugs. The company will raise prices on the blockbuster respiratory treatments it delivers through its Ellipta inhaler, its recently acquired cancer drug Zejula and on several products in its HIV-focused ViiV joint venture, according to 3 Axis Advisors. Price increases ranged between 1% and 5%.
Sanofi said it will raise prices on around 10 of its drugs, with hikes ranging between 1% and 5%. The drugmaker noted the increases are in line with its commitment to not raise prices above medical inflation.
Teva Pharmaceutical Industries Ltd raised prices on more than 15 drugs, in some cases by more than 6%, according to 3 Axis Advisors. A Teva spokesperson said the company regularly reviews prices in the context of market conditions, availability and cost of production.
3 Axis advises pharmacy industry groups on identifying inefficiencies in the U.S. drug supply chain and has provided consulting work to hedge fund billionaire John Arnold, a prominent critic of high drug prices.
STAYING OUT OF THE CROSSHAIRS?
Ian Spatz, a senior adviser at consulting firm Manatt Health, said that drugmakers could be holding to relatively low price hikes in an attempt to stay out of politicians’ crosshairs. Trump, for instance, targeted Pfizer after a proposed round of price increases in 2018, saying in a tweet that the drugmaker “should be ashamed.”
“I’m sure many manufacturers are interested in making sure they are not called out on a large list price increase,” Spatz said.
The United States, which leaves drug pricing to market competition, has higher prices than in other countries where governments directly or indirectly control the costs, making it the world’s most lucrative market for manufacturers.
Trump, a Republican, has struggled to deliver on a pledge to lower drug prices before the November 2020 election. His administration recently proposed a rule to allow states to import prescription drugs from Canada.
The administration had previously scrapped an ambitious policy that would have required health insurers to pass billions of dollars in rebates they receive from drugmakers to Medicare patients.
The House of Representatives, controlled by Democrats, passed a bill earlier in December that would cap prices for the country’s most expensive drugs based on international prices and penalize drugmakers that do not negotiate with the Medicare insurance program for seniors. Trump has threatened to veto the bill, saying it would undermine access to lifesaving medicines.
DURECT (NASDAQ:DRRX) was up 4% premarket on light volume, potentially adding to its 88% rally since December 16. Investors appear to be expecting good news from the FDA’s review of the company’s responses to the CRL it received in February 2014 related to its marketing application for pain med Posimir (bupivacaine) citing the need for more safety data.
