July 20, 2017
ICYMI: Lee and Bipartisan Drug Affordability Cosponsors Urge FDA Commissioner to Reform Anticompetitive Drug Practices
WASHINGTON – U.S. Senator Mike Lee (R-UT), joined by Patrick Leahy (D-Vt.), Senators Chuck Grassley (R-Iowa), and Amy Klobuchar (D-Minn.), are asking Food and Drug Administration (FDA) Commissioner Scott Gottlieb to address anticompetitive practices currently used by some brand-name pharmaceutical companies to delay the manufacture and introduction of generic drugs in the market. Commissioner Gottlieb recently outlined his concerns with such abusive practices, which would be addressed by the bipartisan Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, introduced by the authors of today’s letter and other senators.
The letter will be included in the record as part of the FDA’s public meeting about innovation in drug development and access to affordable drugs titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” The letter discusses abuses of Risk Evaluation Mitigation Strategy (REMS) programs by certain brand-name pharmaceutical companies and urges Commissioner Gottlieb to consider using FDA’s authority to more readily waive the requirement for a single, shared REMS if, after a good faith effort or a reasonable amount of time, a generic drug company has submitted a separate proposal that satisfies REMS requirements. It also cites the need for Congressional action to pass the CREATES Act.
The senators wrote: “While we look forward to hearing more from you about what regulatory actions you believe the FDA can take to address strategies that prevent generics from obtaining samples needed for required regulatory testing and abuses in the REMS program, we believe Congressional action on the CREATES Act is necessary and an essential part of the solution to ending these abuses. We would welcome the opportunity to work with you on this legislative solution.”
The CREATES Act combats anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block the entry of lower-cost generic drugs in the market. The legislation would deter pharmaceutical companies from denying samples to generic companies for product testing and gives the FDA more flexibility to make determinations with respect to single REMS distribution systems.
Full text of the letter can be found here. An outline of the CREATES Act can be found here, and text of legislation can be found here.
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Johnson, Lee Shed Light on Previously Undisclosed HHS Study on Obamacare Premium Increases
WASHINGTON — Sens. Ron Johnson (R-Wis.) and Mike Lee (R-Utah) sent a letter to their Senate colleagues late Wednesday sharing an analysis done by McKinsey & Company for the Department of Health and Human Services (HHS) that shows what Senate conservatives have been saying: Obamacare mandates related to pre-existing conditions, including guaranteed issue and community rating, were the primary drivers of premium increases since Obamacare took effect – accounting for anywhere from 41 to 76 percent of premium increases in the markets the report analyzed. Additionally, a second HHS study sent with the letter found the Consumer Freedom Amendment proposed by Senate conservatives could lead to a significant reduction in premiums.
The Johnson and Lee letter can be found below and the letter and studies can be found here:
July 19, 2017
Dear Colleague:
As the Senate continues to consider the best path forward to fix the damage caused by Obamacare, we write to draw your attention to important analyses that we obtained recently from the Department of Health and Human Services (HHS).
The first analysis is titled "Premium reconciliation and pre-ACA deep dive." According to HHS, the analysis was done by McKinsey & Company at HHS's request and provided to HHS on May 10, 2017. McKinsey analyzed how particular Obamacare mandates affected insurance markets and contributed to increases in insurance premiums. This analysis, prepared by independent and nonpartisan experts, reviewed real market data and is the most granular examination we have seen on the drivers of the premium increases that so many Americans have faced because of Obamacare.
The McKinsey findings are significant. McKinsey examined the factors that contributed to premium increases from 2013 to 2017 across a sample of four states – Georgia, Pennsylvania,Ohio, and Tennessee. McKinsey found that Obamacare mandates related to pre-existing conditions, including guaranteed issue (the requirement that insurers issue plans to any applicant) and community rating (the requirement that insurers charge the same premium to individuals regardless of health status, use of services, etc.), were the chief drivers of premium increases in the markets analyzed. The analysis shows that these mandates, along with other risk factors, have been responsible for 41 percent to 76 percent of the premium increases in the markets analyzed. In Tennessee, for example, these factors were responsible for 73 percent to 76 percent of the 314 percent average monthly premium increase of $327.
The second analysis is titled "Estimating the Effects of the Consumer Freedom Amendment on the Individual Market," dated July 15, 2017. This analysis examines the cost of premiums under the Consumer Freedom Amendment. The results are remarkable. If, under a Consumer Freedom Amendment, insurers were to offer Obamacare-compliant plans and non-Obamacare compliant plans there would be a significant decrease in premiums.
Under Obamacare, individual market monthly premiums would rise to an enrollment weighted average of $845 per month by 2024, according to the analysis. If a Consumer Freedom Amendment with two risk pools is included, by 2024 premiums for Obamacare-compliant plans for a 40-year-old are estimated to be as much as 30 percent lower than the enrollment weighted average. Premiums for non-Obamacare compliant plans are estimated to be as much as 77 percent lower. The report also shows that the single risk pool version of a Consumer Freedom Amendment, which was included in the latest version of the Better Care Reconciliation Act, would lower premiums. However, premiums for non-Obamacare compliant plans in the single risk pool version for a 40-year-old would potentially cost $600 more by 2024 on an annualized basis compared to a two risk pools version.
We are sending these analyses to you to inform our current debate. We hope you find them useful and informative.
Sincerely,
Sen. Ron Johnson Sen. Mike Lee
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. Lee, Leahy, Hoeven, Cruz Introduce Congressional Clerkship Act
WASHINGTON – Today, Sens. Mike Lee (R-UT), Patrick Leahy (D-VT), John Hoeven (R-ND), and Ted Cruz (R-TX) introduced the Daniel Webster Congressional Clerkship Act, a bill that would improve the business of Congress and increase the public’s understanding of its work by establishing a structured congressional clerkship program for recent law school graduates and young lawyers.
“Unlike the Executive and Judicial branches, Congress currently lacks a structured program for recruiting and hiring recent law school graduates,” Sen. Lee said. “Too often this means that new attorneys, who are otherwise qualified and eager to work for Congress, do not even consider a congressional career and are instead pursuing other opportunities.”
“A clerkship can provide invaluable experience to a young lawyer at the start of his or her career,” Sen. Leahy said. “The federal judiciary has long had a clerkship program that teaches recent law school graduates the workings of the judicial branch. Yet there has never been a formal clerkship program in Congress. Creating a pathway for more young lawyers to gain an understanding of how Congress works and the value of public service will lead to a greater embrace of public service. I am proud to join in introducing once again bipartisan legislation to encourage more young lawyers to work in the Congress.”
“Providing recent law graduates with a clerkship in the Senate or the House will help us attract some of the nation’s best and brightest to public service,” Sen. Hoeven said. “The Daniel Webster Congressional Clerkship Act will create a formal program to involve new lawyers in the work of Congress and provide an opportunity for them to see firsthand representative democracy at work.”
“For many years, the brightest young minds coming out of law school have flocked to the federal courts and the executive branch for clerkships and fellowships,” Sen. Cruz said. “Unsurprisingly, this has contributed to the legal profession’s excessive focus on litigation and bureaucratic regulation, at the expense of legislative knowledge and development. The Daniel Webster Congressional Clerkship Act is a small, yet important step in the fight to change that trend. Ideally, the Act will better position Congress to obtain top-notch services from stellar law school graduates, and it will give those graduates access to—and a much better understanding of—the legislative process.”
Committees in the Senate and the House will be responsible to select at least six clerks each year to perform a one-year clerkship. These committees would oversee the selection process in order to guarantee fair allotment between the majority and minority party offices.
“Senators Lee, Leahy, Hoeven, and Cruz are to be applauded for their vision in championing this bipartisan legislation,” said the Coalition’s Steering Committee, comprised of Larry Kramer, former Dean of Stanford Law School; Robin West, law professor at Georgetown University Law Center; Bill Treanor, Dean of Georgetown University Law Center; Abbe Gluck, law professor at Yale Law School; and Dakota Rudesill, law professor at Ohio State.
“The problem is not that Congress does not have enough lawyers,” the Steering Committee noted. “Rather, the problem is that Congress is not competitive for the opportunity to apprentice lawyers on the fast track to the legal profession’s most influential ranks. Congress is missing the opportunity to shape the constitutional perspective of the law’s future leaders. That is because unlike the federal courts, federal agencies, law firms, and law schools, Congress lacks a regularized apprenticeship program that is readily accessible to any top new law graduate, on the basis of objective qualifications,” the Coalition’s Steering Committee emphasized.
This bill is named after Daniel Webster, who is considered one of the most admired and distinguished lawyers and legislators to ever serve in Congress.
An electronic version of this release can be found here.
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Sen. Lee Introduces National Labor Relations Board Reform Bill
WASHINGTON – Today, Sen. Mike Lee (R-UT) introduced legislation that would strip the National Labor Relations Board of its power to prosecute and adjudicate labor disputes.
The “Protecting American Jobs Act” would transfer the power to hear labor disputes to federal courts. The NLRB would retain the power to conduct investigations, but would not be allowed to prosecute them.
“For far too long the NLRB has acted as judge, jury, and executioner, for labor disputes in this country,” Sen. Lee said. “The havoc they have wrought by upsetting decades of established labor law has cost countless jobs. This common-sense legislation would finally restore fairness and accountability to our nation’s labor laws."
The bill is cosponsored by Sens. Ted Cruz (R-TX), James Lankford (R-OK), Tom Cotton (R-AR), Luther Strange (R-AL), and Marco Rubio (R-FL).
The full text can be found here.
