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Presidential Transition Brief
– President-elect Donald Trump has selected CKE Restaurants CEO Andrew Puzder for Secretary of Labor. Puzder has been an outspoken critic of the Affordable Care Act.
President-elect Trump to address drug prices
In his Time magazine Person of the Year interview, President-elect Donald Trump expresses his disapproval of increasing drug prices and vows to take action. While Trump did not elaborate on an approach to combatting price hikes, analysts speculate his statement is meant to encourage pharmaceutical companies to change pricing practices before he takes action. Carolyn Johnson of The Washington Post notes Trump’s statement has already caused a drop in several pharmaceutical stocks.
Drug companies influencing the conversation
The Food and Drug Administration (FDA) often holds public forums to consult with patient advocacy groups on drug approvals. During a recent forum, National Health Council Chief Executive Officer Marc Boutin provided the patient voice in the discussion, but David Hilzenrath of the Project on Government Oversight (POGO) mentions he also brought attention to the influence pharmaceutical companies have in FDA conversations. According to POGO, approximately 93 percent of advocacy groups included in FDA discussions receive pharmaceutical funding. Representatives from pharmaceutical companies also have a significant presence in FDA stakeholder meetings. For the FDA to become more independent of the drug industry, Hilzenrath recommends the agency end reliance on user fees, eliminate requirements to negotiate user fees with a regulated industry, increase the transparency of negotiation and consulting meetings and require conflict of interest disclosures from stakeholders.
Drug spending to reach $1.5 trillion
Global spending for prescription drugs is slated to reach $1.5 trillion in 2021 according to a forecast by QuintilesIMS, an integrated information and technology-enabled health care service provider. Despite the increase, Bill Berkrot of Reuters points out the growth rate is anticipated to decrease from the current rate of nearly 9 percent.
Report: Drug price increases in Vermont
Vermont passed legislation earlier this year to encourage drug price transparency. The measure requires the state to disclose the 15 most costly drugs and those that experienced a significant increase in wholesale acquisition cost (WAC). A report released this week from the state evaluates more than 87,000 drug codes, and finds nearly 10 percent experienced more than a 50 percent increase in WAC pricing. Manufacturers explain many factors determine price increases, including cost effectiveness evaluations, the size of the patient population, investments in research and development and maintenance of facilities to continue to innovate. They continue to criticize the use of WAC pricing as valid data for analysis noting it does not account for discounts and rebates. Zachary Brennan of the Regulatory Affairs Professionals Society reports.
Drug price transparency bill revived in California
Sen. Ed Hernandez (D-West Covina) has introduced a drug price transparency bill. The legislation is similar to a bill he pulled from consideration earlier this year after unsatisfactory amendments by the Assembly Appropriations Committee. The bill, which remains in development, will require pharmaceutical companies to notify states and private insurers of anticipated price increases before they occur. Pauline Bartolone of California Healthline explains the industry is aware of the new bill and looks forward to working with Hernandez as the legislation develops.
Study: No correlation between cancer drugs and improved quality of life
A study published in JAMA Internal Medicine in November 2016 reviewed the effectiveness of and improved quality of life gained from 18 drugs approved by the Food and Drug Administration (FDA) between 2008 and 2012. Of the 13 drugs with available studies, none was found to prolong or improve quality of life. The FDA revoked approval of only one drug despite the findings. According to the FDA, surrogate endpoints, such as the rate at which a cancer progresses for those with life-threatening diseases without many alternative treatments, are also acceptable measures of drug success. Eric Palmer of FiercePharma shares researchers are encouraging the FDA to include overall survival as a surrogate endpoint.
James O’Neill, managing director at Mithril Capital Management, who is reportedly under consideration to head the Food and Drug Administration, has expressed he believes the agency should require companies only to prove drugs are safe before approving them, not that there is a health benefit. Ike Swetlitz and Sheila Kaplan of STAT News have the story.
Earlier this week:
Drugmakers eye ACA replacement warily
Replacing the Affordable Care Act could be a boon or bust for the pharmaceutical industry. Drugmakers are hopeful provisions mandating customer rebates may be rolled back, but are concerned an increase in the number of uninsured Americans could result in fewer consumers, explains Dylan Scott of STAT. Republican lawmakers are also considering drug reimportation, which drug companies oppose.
Senate approves heavily lobbied Cures Act
The Senate passed the 21st Century Cures Act on Wednesday, December 7 by a vote of 94-5. The act will help fight the opioid epidemic, increase funding for cancer and Alzheimer’s research and improve access to mental health care services. Critics of the bill, including Sens. Elizabeth Warren (D-MA) and Bernie Sanders (D-VT), assert it will lower standards for drug approvals and give handouts to pharmaceutical companies. The House passed the bill by an overwhelming margin last week, and the legislation will now go to President Obama to sign into law. Toni Clarke of Reuters has the story.