The Democratic heads of four House committees last week again demanded answers from top U.S. health officials about why the Trump administration is not defending the Affordable Care Act in a lawsuit being fought in Texas.
The committees' ranking members — Energy and Commerce's Frank Pallone of New Jersey, Judiciary's Jerry Nadler of New York, Ways and Means' Richard Neal of Massachusetts and Education and the Workforce's Bobby Scott of Virginia — said they have been waiting for a response to their initial letter to the Trump officials since June.
In declining to defend the ACA, the Trump administration is seeking to invalidate "critical patient protections and once again subject millions of Americans with preexisting conditions to the discrimination they faced" before the 2010 law was enacted, the four Democrats said.
Last month, Nadler said he plans to investigate the administration's refusal to defend the ACA — a duly enacted federal statute — when he takes the helm of the Judiciary Committee in January.
Once in control, House Democrats also plan to ask a judge in January to let them intervene in the lawsuit, which was filed by 20 Republican state attorneys general.
Enrollment in health plans offered through the ACA marketplace has continued to lag — down 11% in the first five weeks versus year-ago figures. The Centers for Medicare and Medicaid Services reported on Dec. 6 that about 3.2 million Americans had signed up for the ACA plans for 2019, compared with 3.6 million by the fifth week of enrollment in 2017.
Last year, the Trump administration slashed the ACA marketplace's annual open enrollment period in half — shortening it from three months to six weeks. It ends Dec. 15.
HHS also substantially cut grants for navigators — people who help enrollees understand their options and help them with paperwork to obtain financial help and assess provider networks. In addition, the agency sharply reduced the funds for advertising about the enrollment period.
"The latest ACA numbers suggest the drop in sign-ups is primarily due to lack of awareness and possibly mandate repeal, more than lack of appealing plans," Cynthia Cox, director of health reform and private insurance at the nonprofit, nonpartisan Kaiser Family Foundation, wrote Dec. 6 on Twitter.
An analysis by the nonprofit Media Matters also found that the major U.S. television networks have given scant coverage to the ACA enrollment period — devoting a combined total of 16.5 minutes to the topic since Oct. 3.
Other factors, such as the distraction of the recent midterm elections in November and the low unemployment in the U.S., may also have contributed to the lower enrollments, Larry Levitt, senior vice president at Kaiser, tweeted.
Biotech's Burrill gets sentenced to 30 months in prison
Steven Burrill, one of the most well-known venture capitalists in the biotech community, was sentenced last week to 30 months in prison on charges of investment-adviser fraud and tax evasion.
Burrill was the owner and CEO of Burrill & Co., Burrill Capital Management LLC and a number of related entities, where he managed venture capital funds, including the Burrill Life Sciences Capital Fund III LP, a $283 million investment fund focused on the life sciences industry.
In a 34-count indictment, prosecutors stated that between December 2007 and September 2013, Burrill misappropriated $18 million, siphoning it from the fund and moving it to his management companies.
He had faced the possibility of spending up to 30 years in jail.
Burrill was barred permanently from the securities industry under a March 2016 settlement with the Securities and Exchange Commission. He was indicted by a federal grand jury in September 2017 and pleaded guilty three months later to one count of investment-adviser fraud and one count of tax evasion.
Burrill was known among drugmakers for his popular annual state of the biotech industry reports, which he presented each year at the Biotechnology Innovation Organization's annual international convention.
HHS names new drug pricing czar
John O'Brien was named the Trump administration's new drug pricing czar last week, replacing Dan Best, who died Nov. 1.
O'Brien previously was an adviser to Health and Human Services Secretary Alex Azar and deputy assistant secretary for health policy at the agency.
Before joining HHS in 2017, O'Brien was vice president of public policy at CareFirst BlueCross BlueShield.
One of the first jobs O'Brien took on in his new role was defending the administration's idea of having the government's Medicare program that covers expensive injectable medicines for cancer and other complex diseases for seniors and disabled Americans, known as Part B, use an international price indexing system to pay for the therapies.
Right now, HHS has only issued an advance notice of proposed rulemaking, a bureaucratic mechanism used to gauge public opinion ahead of making a formal proposal. Opposition against the idea has been growing.
O'Brien disputed the claims by brand-name drug industry lobbyists that the administration was trying to impose "foreign price controls."
"Free market advocates and those who have philosophical concerns about government price fixing should be among the most vocal opponents of the status quo," O'Brien wrote in a Dec. 6 blog posted on the HHS website.
The way Medicare Part B pays for drugs now is "a crazy system," O'Brien said. "And it has to change."
FDA appoints permanent new drugs chief
Peter Stein was appointed last week as the new director of the Office of New Drugs at the U.S. Food and Drug Administration.
Stein had been the office's deputy director since 2016.
FDA Center for Drug Evaluation and Research Director Janet Woodcock has been simultaneously filling in as acting chief of the new drugs office over the past two years after the retirement of its long-time chief, John Jenkins, who had held the job since 2002.
Top FDA officials have proposed overhauling both the Office of New Drugs and its review processes, though the agency needs congressional approval to make the changes.
"Peter has played an instrumental role in driving this long-term process of continuous improvement, which focuses on therapeutic and disciplinary alignment of our offices and divisions, workload management, operational efficiency and staff development and advancement," Woodcock said last week in a memo to her staff, obtained by S&P Global Market Intelligence.
Before joining the FDA, Stein was the vice president of late-stage development, diabetes and endocrinology at Merck & Co. Inc.
In a separate memo, Woodcock said Robert Temple, who has worked in a number of positions at the FDA since 1972 — most recently the deputy director for clinical science and the acting deputy director of the Office of Drug Evaluation I — is moving to a new position as senior adviser within the Office of New Drugs. Temple will advise Stein and other FDA officials on matters related to clinical program objectives.
FTC comments on FDA petition abuse
Also last week, the U.S. Federal Trade Commission told the FDA that it shared the drug agency's concerns about the abuse by some brand-name biopharmaceutical companies in using the citizen petition process to delay competition of lower-cost generic medicines or biosimilars, which are intended to be cheaper versions of biologic therapies — products derived from natural sources, such as microorganisms or plant or animal cells.
"We stand ready to work closely with the FDA on citizen petition abuse and other issues that may harm competition," the FTC said in comments submitted to the drug agency about a revised set of guidelines it issued in October.
The FTC said it has a long-standing interest in "sham petitioning and other abuses of government processes that may inhibit competition."
While some citizen petitions submitted to the FDA raise genuine issues for scientific consideration, "many petitions do not" and divert the agency's time and resources, the FTC said.
NIH tissue chips in space
Among the new research experiments that launched Dec. 5 aboard the Spacex SA Dragon cargo vessel to the International Space Station were a few dozen tissue chips, which are 3D devices loaded with human cells grown on an artificial scaffold to model the structure and function of human tissue.
The tissue chip experiments are being funded by the U.S. National Institutes of Health.
The initial set of tissue chips sent to the space station are intended to model the various aspects of the human immune system. They were the first in what is expected to be a series of tissue chip experiments to fly to the space station — a research laboratory orbiting more than 220 miles above the Earth where scientists test their hypotheses and experiments in a microgravity environment, which can mimic the atmosphere inside the human body and whose effects on physiology can imitate the processes of aging and some diseases.
Other tissue chips will model the lungs, kidneys, bone and cartilage as well as the blood-brain barrier, NIH Director Francis Collins wrote in a blog last week.
A number of drugmakers, including Merck, and research organizations, such as the Michael J. Fox Foundation, also have tested projects on the space station.