Vol. 5, Num. 9: Drugmakers costing US $$, 'Right to Try' Bill Approved, Restrictions on Abortion Funding, Gene Therapies, $7M to Fight Ebola Outbreak, VT Passes Drug Import Law, Fix VA Med Records, FDA Approves Migraine Medicine



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May 25, 2018 

Volume 5, Number 9

In This Issue

Drug Makers Costing US Billions

Congress Approves ‘Right to Try’ Bill

Plan to Restrict Abortion Funding

Gene Therapies Get Easier FDA Path

$7 Million Contribution To Fight Ebola Outbreak 

VT Passes A Drug Importation Law

Gov’t Approves Deal To Fix VA Medical Records

FDA Approves Migraine Medicine

US Uninsured Rate Holds Steady

Insurers Profitable By Raising Premiums

Trump Admin Can Reclaim Unspent Money

IRS Updates on HSA Limits

TJG On Facebook

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Kaiser Health News: Drug makers Blamed For Blocking Generics Have Milked Prices And Cost U.S. Billions
Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found. As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts. (Lupkin, 5/23)

Source: Kaiser

The New York Times: Congress Approves Bill Giving Patients A ‘Right To Try’ Experimental Drugs
The bill would, in effect, allow dying patients to bypass the Food and Drug Administration and obtain an “investigational drug” with the approval of their doctors, if the drug manufacturer agrees to supply it. On at least three occasions in the past four months, Mr. Trump has urged Congress to pass the bill. “Patients with terminal conditions, and terminal illness, should have access to experimental treatment immediately” and “should not have to go from country to country to seek a cure,” he said in January in his State of the Union address. (Pear, 5/22)

Source: The NY Times

The Wall Street Journal: Trump Administration To Advance Plan To Restrict Funding For Abortion Providers
The Trump administration will move ahead with restrictions on funding access for family planning providers that offer abortion services, the Department of Health and Human Services said Tuesday. The announcement came shortly before President Donald Trump was addressed the annual gala of the Susan B. Anthony List, a group that supports antiabortion candidates for federal office. There, Mr. Trump said his administration had made a “historic announcement” and “kept another promise.” (Radnofsky, 5/22)

Source: The Wall Street Journal

Bloomberg: Gene Therapies That Could Transform Diseases Get Easier FDA Path 
Unlike traditional drugs, gene therapies are intended to be given once, transform the inner workings of the body and last for a lifetime. For regulators, the challenge is to find ways to get the new therapies to desperate patients while balancing the need to monitor their long-term safety for years after approval, FDA Commissioner Scott Gottlieb said Tuesday. “For some of these products, there’s going to be some uncertainty, even at the time of approval,” Gottlieb said in a speech at the Alliance for Regenerative Medicine’s annual board meeting. “But these products are initially being aimed at devastating diseases, many of which are fatal and lack available therapy. In these settings, we’ve traditionally been willing to accept more uncertainty to facilitate timely access to promising therapies.” (Cortez, 5/22)

Source: Bloomberg

The Hill: US To Contribute Up To $7 Million To Fight Ebola Outbreak
The U.S. will contribute up to $7 million to fight an Ebola outbreak in the Democratic Republic of Congo (DRC), Health and Human Services Secretary Alex Azar announced Tuesday. Azar made the announcement in Switzerland at the World Health Assembly, the decision making body of the World Health Organization (WHO), while urging other member states to contribute to "ensure we defeat this outbreak."  (Hellmann, 5/22)

Source: The Hill

Kaiser Health News: Vermont Legislators Pass A Drug Importation Law. So What?
This week, Vermont passed a first-in-the-nation law that would facilitate the state’s importation of prescription drugs wholesale from Canada. It represents the state’s effort to tackle head-on the issue of constantly climbing drug prices. Other states, including Louisiana and Utah, have debated similar legislation and are watching Vermont’s progress closely. (Luthra, 5/18)

Source: Kaiser Health News

The Associated Press: Gov't Approves $10B Deal To Overhaul VA Medical Records
The government approved a $10 billion deal Thursday to overhaul the electronic health records of millions of veterans, part of a bid to improve wait times and expand access to doctors outside the Veterans Affairs system. The aim of the contract with Cerner Corp. is to provide veterans easy access to their health records upon leaving active-duty service and when they receive medical treatment at a VA facility or a private doctor referred under the VA's Choice private-sector program. (5/17)

Source: The Associated Press

The Wall Street Journal: FDA Approves Migraine Medicine
Currently, said Dr. Kadrie, clinicians tend to use drugs such as blood-pressure medicine and drugs for seizures that “happen to prevent migraines.” It is estimated that in the U.S., more than 37 million people suffer from migraines, and there are studies suggesting that as many as 13% of the adult U.S. population have them, including two million to three million who are chronic sufferers. The condition tends to be about three times as frequent in women as in men, and is especially prevalent in the age group between 35 and 55 years old. (Burton, 5/17)

Source: The Wall Street Journal

The New York Times: US Uninsured Rate Holds Steady, CDC Survey Shows

Margot Sanger-Katz writes for the New York Times (5/22, Subscription Publication) “TheUpshot” blog that despite the Trump Administration’s attempts to repeal the Affordable Care Act, a survey from the Centers for Disease Control and Prevention found that the uninsured rate “remained flat at 9.1 percent in the first year of the Trump presidency.” Sanger-Katz says, “The numbers suggest a surprising resilience of the health law, and its expansion of insurance coverage, even in the face of efforts that the law’s defenders call ‘sabotage.’” Overall, the figures over the years show the ACA has “substantially reduced the number of Americans without insurance” by around 19.3 million people between 2010 and 2017.

Source: NY Times

Bloomberg News: Insurers That Sell ACA Plans Became Profitable By Raising Premiums Significantly, Analysis Reveals

Bloomberg News (5/17, Tracer) reports that following “years of losses, the U.S. health insurance industry figured out how make money from Obamacare last year,” a new analysis conducted by the Kaiser Family Foundation revealed. Insurers did so by raising premiums. Data show that on average, the cost of “plans sold in the individual market climbed about 22 percent in 2017, as insurers boosted premiums well above what they spent on medical care.”

Source: Bloomberg

Politico: GAO Confirms Trump Administration Can Reclaim Unspent Money, Including $7 Billion In CHIP Funding

Politico (5/22, Ferris) reports that on Tuesday, the Government Accountability Office “delivered a victory to the Trump administration by greenlighting a proposal to claw back more than $7 billion in unused cash from the Children’s Health Insurance Program.” The article says the GAO approved most “of the administration’s $15.3 billion plan to cancel spending.” In light of this, “the White House’s plan for so-called rescissions will likely retain its filibuster-proof powers in the GOP-controlled Senate, easing the way for potential passage with a simple majority vote.”

Source: Politico

IRS Updates Decision On 2018 HSA Limits

The 2018 HSA family contribution limit is back to $6900. On April 26th, the IRS updated its decision to decrease the 2018 maximum contribution limit for family coverage only. The maximum annual contribution limit for family coverage limit is now back to $6,900. Earlier this year, the IRS had adjusted the maximum contribution limit for family coverage from $6,900 to $6,850. Yesterday the IRS updated its decision. To view the official IRS announcement, please visit the Internal Revenue Service press release.

Source: IRS


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