HealthCare Roundtable e-News – February 12, 2019

Public Sector HealthCare Roundtable Signs Letter Supporting CREATES Act 

The Roundtable recently pledged its support for the reintroduction of the bipartisan Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act) sponsored by Sens. Patrick Leahy (D-Vt.) Sens. Chuck Grassley (R-Iowa), Amy Klobuchar (D-Minn.), and Mike Lee (R- Utah) of the Senate Judiciary Committee. The bipartisan bill will prevent name-brand drug companies from using anticompetitive tactics to block the entry of generic drugs into the market. “When these companies use unfair practices to keep drug prices artificially high, patients suffer,” said Sen. Leahy in a statement. Patients, families and government programs shouldn’t have to cope with increased drug costs to help name-brand companies’ bottom lines.” The Congressional Budget Office released estimates stating that the bill would result in $3.9 billion savings as well as increased savings for consumers and health plan purchasers.

Read the final group support letter, signed by the Roundtable.

Ways & Means Convenes Drug-Pricing Hearing Today, Feb. 12

A drug-pricing hearing is scheduled to be held today (Feb. 12) by the House Ways & Means Committee. This is the fourth hearing scheduled by House and Senate committees in recent weeks on the topic of drug pricing reform. Chairman Richard Neal (D-Mass.) announced that former MedPAC Executive Director Mark Miller would be testifying in addition to Dr. Joe Antos of the American Enterprise Institute. More information can be found here:

In his opening statement, Chairman Neal said While health care innovation is part of the economic fabric of my home state of Massachusetts, and medical research has opened the door to numerous breakthroughs, the high cost of this innovation often gets excessively passed to the consumer.” The Senate Finance and House Oversight and Reform committees held hearings with expert testimony last week, and the Senate Finance Committee will hold a follow-on hearing with several senior executives from drug companies testifying. More information on the previous Senate Finance Committee hearing can be found here:

FDA Returns to Normal Operations Post-Shutdown

While many federal employees are recovering from the most recent government shutdown and preparing for the possibility of another in the near future, the FDA has confirmed that the agency’s user fee-funded activities are expected to return to normal operations and workload in the coming days. (InsideHealthPolicy).

The agency saw nearly half of its staff being furloughed during the shutdown and had stalled its collection of new user fees and applications for medical devices. At the time of the shutdown, Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), and the medical device lobby put forward a legislative proposal that would allow the FDA to continue collecting information to ease the backload as it begins to operate post-shutdown.

While the approvals process could take a little longer than usual, Aaron Josephson, a senior director at ML Strategies and former senior policy advisor at FDA’s device center, stated, “It is possible a few submissions may take longer than normal to review because of workload management issues, but I would be surprised if the FDA is not able to meet its user fee goals because of the shutdown.” (InsideHealthPolicy)

FDA Commissioner Scott Gottlieb took to Twitter during last month’s shutdown, insisting that the FDA was taking steps to “expand the scope of food safety surveillance inspections we’re doing during the shutdown to make sure we continue inspecting high-risk food facilities.” He noted that “31% of our inventory of domestic inspections are considered high risk.”

Energy & Commerce to Expected to Review Trump ACA Policies During Feb. 13 Hearing

The House Energy & Commerce health subcommittee is preparing for a hearing this Wednesday (Feb. 13) following the panel’s first hearing of the new session, which focused on the Texas v. Azar lawsuit. According to committee Chairwoman Anna Eshoo (D-Calif.), the panel will consider and evaluate legislation that would revive the Affordable Care Act’s advertising budget, revoke the short-term health plan rule and review several policies that House Democrats claim undermine the ACA. (InsideHealthPolicy).

“The Trump Administration has done its very best to undermine the Affordable Care Act and access to quality healthcare for millions of Americans. Our legislation would help to ensure that those protections do not fall victim to partisan attacks. I’m committed to working with my colleagues to strengthen and improve access to quality,” said Rep. Annie Kuster (D-NH).

Aviva Aron-Dine of the Center on Budget Policy and Priorities claimed that in reviewing the short term plans currently available none offered maternity care, 43 percent of the plans did not cover mental health, 62 percent did not cover substance abuse treatment and 71 percent did not cover outpatient drugs. (InsideHealthPolicy).

FDA Seeks to Boost Generic Competition with Help from International Partners

The FDA is continuing to bolster its efforts to improve generic drug competition by adjusting exploring ways to collaborate internationally with other countries. The push comes as HHS looks to further address situations in which limited generic competition has given companies free rein to raise the prices of medicines, according to HHS Secretary Alex Azar.
The FDA announced last October that it would be partnering with International Council for Harmonization of Technical Requirements for Pharmaceutical for Human Use to relaunch key initiatives supporting the Drug Competition Action Plan. The FDA announced the partnership in an effort to advance the international harmonization of scientific and technical standards for generic drug development.

“In some cases, the U.S. market for a generic drug may not be big enough to attract a second or third manufacturer to keep prices low, but the combined market of the United States and other wealthy nations certainly would be,” Azar told the generic industry lobby.

According to the ICH’s group website, Europe, Japan, Canada, Brazil and China are some of the many countries who participate. In a statement, FDA Commissioner Scott Gottlieb said that “given the globalization of generic drug development and the basic commonalities in technical requirements among different regulatory agencies, a more harmonized generic drug development process [with international partners] is attainable.”