With help from Leah Nylen and Arthur Allen
— FDA’s tech overhaul is underway says Principal Deputy Commissioner Amy Abernethy
— Painkiller week at FDA with a handful of meds up for advisory committee debate.
— Trump’s drug pricing ad rule hits another legal roadblock.
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FDA’S TECH OVERHAUL IS UNDERWAY — The agency is pulling inspiration everywhere from the Pentagon to agile tech companies in a push to modernize its IT infrastructure and data strategies, FDA Principal Deputy Commissioner Amy Abernethy told POLITICO.
The oncologist, who joined the FDA a little under a year ago from the Roche-owned health tech company Flatiron Health, is heading up a three-pronged tech modernization plan aimed at overhauling the agency’s mountains of data and eventually speeding up review processes.
FDA used the Pentagon as a model for its new data storage and management techniques as the agency shifts toward cloud-based data that can be used and exchanged rapidly in the future, Abernethy said in an interview. “But culturally, we are looking to look more like a solid-looking technology company that is able to pull together teams in a very efficient way,” she said. “Governments tend to be pretty hierarchical and fixed.”
The modernization plan is a priority for new commissioner Stephen Hahn. “That is where Dr. Hahn’s interests and excitement lies. As we build a robust and durable technical organization, it allows us to do a number of things.”
The potential starts with a speedy safety data reporting plan that the agency is phasing in over two years after a five-company pilot program proved a success.
“If we can start receiving safety data that way, think about all the other kinds of information we can receive directly from industry and in other places,” she said. “It starts to set the stage for moving from massive applications that are 300-page PDFs to now, component information that can be more rapidly analyzed.”
AND A DATA CHALLENGE — FDA Monday announced a challenge that will allow scientists to use its data to detect possible drug-related adverse event patterns. The contest, which starts Friday and ends Feb. 28, offers no cash award, but is intended to bolster FDA’s existing data mining and case review approach to finding safety problems.
The full announcement will be available on Friday here. To attract talent it should be publicized widely not only among data scientists but also social scientists who may have good ideas for detecting anomalies, said Raj Ratwani, director of the MedStar Health National Center for Human Factors in Healthcare.
“Drug safety events don’t occur in a vacuum, and FDA data is only one piece of the puzzle,” said Ben Moscovitch, who leads EHR safety efforts at the Pew Charitable Trusts. “Other factors—such as the design, implementation, and use of EHRs—can lead to the harm.”
FDA KICKS OFF STRING OF PAIN DRUG ADCOMS — The FDA will review a handful of pain medications this week, including some new opioids, as the country continues to struggle with misuse and addiction to narcotics.
Members of Congress have criticized the FDA in recent years for approving new opioids. But the agency defended the role of drugs in the treatment of chronic pain in documents prepared by the agency in advance of today’s meeting to consider Nektar Therapeutics’ oxycodegol. FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will consider the drug to manage chronic low back pain in adults who require around-the-clock, long-term treatment for whom other treatment options are inadequate. They will also consider approving the drug more generally for chronic pain.
Rigoberto Roca, acting director of FDA’s addiction medicine and pain medicine division, pushed back against claims that opioids are not proven to be effective beyond 12 weeks, the typical length of clinical trials testing for effectiveness. “An absence of evidence has been misinterpreted as evidence of an absence of effect,” he wrote. Roca also rejected the idea of “absolute limits” on the total daily dose of opioids for pain management.
Diana Zuckerman, a drug safety expert at the National Center for Health Research, said the panel should reject oxycodegol. The key trial for the drug had a high dropout rate and it performed only marginally better than placebo, she said. “Instead of comparing it to over-the-counter pain medications they compared it to nothing and yet it had little impact for a small amount of time,” she said.
… On Wednesday, the advisory committees will discuss two more. The morning docket holds Esteve Pharmaceutical’s application for a drug combination of the opioid tramadol and the anti-inflammatory celecoxib, to treat acute pain in adults. Esteve says the pill offers a safer alternative to other pain relievers by including lower-than-recommended doses of each drug, according to FDA materials for the meeting, but the company presented no data to conclude that the combination is better or worse than other approved pain relievers. Tramadol was less frequently implicated in prescription opioid misuse than hydrocodone and oxycodone, but overdose deaths involving it increased from 2011 to 2017.
In the afternoon session the committees will discuss Aximris XR, an extended-release oxycodone pill designed to make it hard to crush the drug so it can be snorted or injected. The committee voted 22-1 to reject an earlier version submitted in 2017 under the name Rexista; at the time it contained a blue dye that was released when the pills were crushed. But the dye hadn’t been tested for safety and some panel members felt that rather than discouraging use, blue lips might make the drug attractive to abusers. Like the older version, the new drug contains a material that makes it gel in an unappealing way when crushed.
On Thursday the Anesthetic and Analgesic Drug Products panel considers Durect’s bupivacaine, a non-opioid anesthetic, proposed for post-surgical pain.
WOODCOCK LAYS OUT 2020 PRIORITIES — The agency’s Center for Drug Evaluation and Research Director Janet Woodcock laid out more than a half dozen strategic goals for 2020 in an email to staff Monday.
FDA will kick off its next round of negotiations with industry for the 2022 reauthorization of the prescription drug, generic drug and biosimilar user fee programs this year, she wrote. The drug center will also work on its efforts to modernize new drug approvals by fully implementing a new streamlined, interdisciplinary review process and template, she said. On drug compounding, Woodcock said FDA will continue to develop new ways to engage with outsourcing facilities, which are allowed to compound medicines in larger quantities as long as they follow certain manufacturing practices. Addressing the opioid crisis, drug shortages, and post-marketing safety also were high on her priority list for the new year.
To accomplish all of the drug center’s 2020 goals Woodcock said the agency is working to improve CDER’s governance structure, information technology and hiring.
TRUMP DRUG PRICING RULE HITS ANOTHER ROADBLOCK — HHS appeared to have failed Monday to convince a federal appeals court panel that it has the authority to require drug companies to disclose the list price of their medicines in TV advertisements.
Comments from the three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit indicated they were unlikely to reverse a July district court ruling that HHS lacks the authority to compel manufacturers to disclose list price. Major drugmakers and the Association of National Advertisers challenged the rule.
The judges were not convinced that the rule helps HHS ”efficiently administer” the Medicare and Medicaid program. HHS argues it has the authority to issue the rule as part of its legal mandate from Congress to enact regulations to efficiently administer the program. The judges also were not convinced the rule would help the government control drug costs; at least one judge seemed to feel Congress gave FDA, not CMS, the sole power to regulate drug ads.
ABBVIE ‘PAY FOR DELAY’ HEARING KICKS OFF, AGAIN — AbbVie heads to court Wednesday morning in Philadelphia to appeal a $448 million judgement on its profits over allegations it violated antitrust law, our antitrust reporter Leah Nylen writes.
The FTC, in a separate appeal related to the same case, will argue that a lower court shouldn’t have thrown out claims that an authorized generic licensing deal between AbbVie and Teva over cholesterol drug Tricor was anticompetitive.
The background: A federal judge ruled in the FTC’s favor in 2018, arguing that an AbbVie predecessor — Unimed Pharmaceuticals, a unit of Solvay — and Besins Healthcare filed frivolous patent litigation against Teva and Perrigo in 2011. That sham litigation delayed entry of a generic version of the testosterone replacement gel AndroGel, the judge found. AbbVie owns AndroGel, while Besins co-owns the underlying AndroGel patent.
The same judge rejected a separate FTC claim stating that the patent litigation settlement — which included a $175 million licensing deal between AbbVie and Teva over Tricor — amounted to a “pay-for-delay” agreement in violation of antitrust law.
The FTC’s case against AbbVie is its first fully litigated challenge against a pharmaceutical company since the Supreme Court’s landmark Actavis decision in 2013. The high court ruled that agreements to delay generic entry may violate the antitrust law, but left it up to lower courts to determine whether particular agreements are problematic.
HOUSE HEARING ON MARIJUANA BILLS — The House Energy and Commerce Health Subcommittee hearing will consider a half-dozen marijuana bills, ranging from medical research proposals to comprehensive legalization blueprints, POLITICO’s Paul Demko writes.
The hearing will feature testimony from three experts from government agencies: Matthew Strait, a senior policy adviser at the Drug Enforcement Administration; Douglas Throckmorton, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research; and Nora Volkow, director of the NIH’s National Institute on Drug Abuse.
Volkow told POLITICO last week that cannabis and in particular CBD may have potential for pain and addiction treatment but that it’s been difficult to do research because the plant is in DEA’s most restricted drug class. Lawmakers are likely to grill FDA’s Throckmorton on the status of CBD regulations meant to clear up how the popular cannabis byproduct can be marketed.
DEVICE INDUSTRY’S 2020 PRIORITIES: DIGITAL — The device industry’s bete noire — the 2.3 percent tax included in the Affordable Care Act — is gone. The industry can now focus its advocacy efforts on some new priorities, and they’re mostly digital, representatives of trade groups AdvaMed and MITA told Darius Tahir.
AdvaMed says the new crop of privacy bills nationwide could pose unintended consequences for clinical research: If they, like the California Consumer Privacy Act, give control of data to individuals, the trade group worries that could foul up research, as study participants could request their data be deleted by a researcher, scrambling the results.
Meanwhile, artificial intelligence is preoccupying MITA. The organization’s executive director, Patrick Hope, said the technique has the potential to improve imaging by reducing the amount of radiation delivered in each image. But, he said, MITA would like greater reimbursement for artificially intelligent imaging and a more predictable approval process from FDA.
EXPANDING MEDICAID REDUCED OPIOIDS DEATHS — Medicaid expansion was associated with reductions in total opioid overdose deaths, particularly those involving heroin and synthetic opioids other than methadone, according to a study published in JAMA Network Open. However methadone-related mortality went up between 2011 and 2017 in states that expanded Medicaid.
Researchers wrote that states invest more resources in addressing the opioid overdose epidemic, they should keep in mind that Medicaid expansion could help reduce opioid overdose mortality through greater access to addiction treatments. Some Republicans such as Sen. Ron Johnson (R-Wis.), have alleged that Medicaid expansion is fueling the rise of the opioid epidemic because of increased access to care, but researchers at UPenn have also debunked that theory.
OKLAHOMA SETTLES WITH DRUGMAKERS ON OPIOIDS — The state on Friday announced that it will receive $8.75 million from two Endo International subsidiaries, Endo and Par Pharmaceuticals. Oklahoma had planned to sue the company, alleging it deceptively marketed opioids and underplayed their potential for addiction. Endo in 2016 withdrew its opioids, Opana and Opana ER, at FDA’s request.
Oklahoma last year settled with Purdue and Teva Pharmaceuticals for $270 million and $85 million, respectively, before a scheduled trial for similar allegations. A judge later ordered Johnson & Johnson, the remaining manufacturer in the lawsuit, to pay the state $465 million.
FDA, NIH AREN’T USING THEIR NEW POWERS TO ENFORCE TRIAL REPORTING — A 2017 rule meant to ramp up enforcement of companies, universities and others that fail to report research results to the federal database clinicaltrials.gov hasn’t led to the aggressive crackdown on misbehavior the government promised, Charles Piller reports for Science. NIH for example, has failed to cut off grants to entities that don’t follow through on trial reporting requirements. And FDA says it won’t’ enforce penalties of more than $12,000 a day for failing to report results until it issues additional guidance on the topic, Piller writes. While there has been an improvement in trial reporting since the rule, many organizations still aren’t reporting results, Piller found. NIH itself had a poor performance in documenting its trial findings.
The FTC approved a final order for Celgene to divest its drug Otezla, clearing the way for Bristol-Myers Squibb to complete its $74 billion acquisition of Celgene. The $13.4 billion divesture of Otezla to Amgen was the largest ever required by the DOJ.
FDA provided an update on post-marketing activities for Essure, the discontinued permanent birth control implant.
CVS Chief Medical Officer Troy Brennan outlined in a white paper an approach to managing high-cost gene therapies
The Institute for Clinical and Economic Review issued a final report and policy recommendations on JAK inhibitors for rheumatoid arthritis.
ICER also released an evidence report on acute treatments for migraines.
FDA issued draft guidance on the qualification process for drug development tools.
FDA also issued final guidance on developing dried plasma products for transfusion and recommendations for information to be included in test reports for non-clinical bench performance testing of certain devices.
Biogen will acquire an early-stage experimental Alzheimer’s treatment from Pfizer for $75 million and possible milestone payments.
Former FDA commissioner Margaret Hamburg and former Sen. Bill Frist wrote in Health Affairs about growing health care spending.
