Grassley, Klobuchar Seek Answers on Prescription Drug Importation Policies
WASHINGTON – Sens. Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) sent a letter to Food and Drug Administration (FDA) Commissioner Scott Gottlieb seeking information regarding FDA policies on imported prescription drugs from Canada.
A recent Kaiser Health News article reported that FDA sent criminal investigation agents to nine Florida stores that help patients buy prescription drugs from pharmacies in Canada. “Although the Federal Food, Drug, and Cosmetic Act prohibits the importation of unapproved drugs, the FDA has long focused its enforcement efforts on ‘products apparently intended for the commercial market and on fraudulent products, and those that pose an unreasonable health risk.’” “We are concerned that a November 20, 2017 report by Kaiser Health News may indicate a change in this longstanding policy. It is our understanding that these stores solely assist patients who prefer to purchase prescription drugs from outside the United States – including by helping patients avoid websites that sell fraudulent or unsafe products – and do not dispense drugs themselves. We are concerned that the Food and Drug Administration (FDA) may be taking actions to scale back the agency’s ‘non-enforcement policy’ that currently allows for limited importation of prescription drugs.”
The letter is the latest in a continuing effort by Sens. Grassley and Klobuchar to find solutions to the ever-increasing costs of prescription medications. Earlier this year, they introduced S. 974, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which would address abuses in the Risk Evaluation and Mitigation Strategies (REMS) program by deterring pharmaceutical companies from denying samples to generic companies for product testing and by giving the FDA more flexibility in making REMS distribution systems.
In February, Sens. Grassley, Klobuchar and McCain urged then- Department of Health and Human Services (HHS) Secretary Tom Price to use his statutory authority to fast track the importation of prescription drugs from Canada under certain circumstances as a remedy to recent drastic drug price increases in the United States. They also wrote to Commissioner Gottlieb asking him to address anticompetitive practices currently used by some brand-name pharmaceutical companies to delay the manufacture and introduction of generic drugs in the market. They further urged him to address abuses in the regulatory process that delay competition and increase prescription drug costs.
The letter can be found here
Grassley, Ernst Receive Response from VA on Hiring Practices, Press for More Answers
WASHINGTON – Responding to a December 4, 2017, letter from Sens. Chuck Grassley and Joni Ernst, the U.S. Department of Veterans Affairs (VA) today said that the Iowa City VA doctor in question is no longer a VA employee and that they have “issued a new policy to ensure full compliance with the law and a national review to verify that this policy is being implemented correctly.” This follows a disturbing report that shed light on hiring practices at VA hospitals, including the Iowa City VA. While the Iowa senators are pleased to hear that actions to correct these missteps are taking place, they are calling for more answers to their questions.
The full text of Senator Grassley and Ernst’s letter is available here and below.
The VA’s December 21 response letter can be found here.
Senator Grassley and Ernst’s original December 4 letter to the VA is available here.
Grassley, Klobuchar, Tillis Bill to Aid Families of Missing Autism, Alzheimer’s Patients Passes Senate
WASHINGTON – Bipartisan legislation to help families locate missing loved ones with Alzheimer’s disease, autism and related conditions has unanimously passed the U.S. Senate. Kevin and Avonte’s Law (S. 2070), named in honor of two boys with autism who perished after wandering from safety, would also support training for caregivers to prevent and respond to instances of wandering. The bill, led by Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa), Senator Amy Klobuchar (D-Minn.) and Senator Thom Tillis (R-N.C.), is now pending approval in the U.S. House of Representatives.
“The feeling of dread and helplessness families must experience when a loved one with Alzheimer’s or autism goes missing is unimaginable. But when communities are empowered to lend a hand, these terrifying situations can have happy endings. Kevin and Avonte’s Law, named for a boy from Jefferson, Iowa and a boy from New York City, makes resources available for technologies that advance the search for missing children, along with specialized training for caregivers and first responders to help prevent wandering by vulnerable individuals,” Grassley said. “I look forward to its swift passage in the House of Representatives.”
“We need to do everything we can to make sure that kids like Hamza Elmi from St. Cloud – and all people with a developmental disability or a form of dementia – make it home safely,” Klobuchar said. “Passing this bipartisan bill into law will mean first responders, law enforcement officers, caregivers, and Minnesota families will have access to the technology, resources, and training they need to prevent wandering and find missing people.”
“I’m pleased to see the Senate unanimously pass Kevin and Avonte’s Law, which will support training for caregivers to prevent and respond to missing individuals with Alzheimer’s disease, autism, and related conditions,” said Tillis. “This legislation has a deep personal meaning for me, as I was a caregiver for my grandmother during her battle with Alzheimer’s disease. We should be moving heaven and earth to help families and caregivers reunite with loved ones who wander and disappear, and Kevin and Avonte’s Law can truly make a difference in preventing tragedies and give families across America a greater peace of mind.”
Information on the introduction of this legislation is available HERE, a bill summary can be found HERE and full text of the legislation can be found HERE.
In addition to Senators Grassley, Klobuchar and Tillis, the bill is also sponsored by Senators Chuck Schumer (D-N.Y.), Dick Durbin (D-Ill.), Richard Burr (R-N.C.), Chris Coons (D-Del.), Dianne Feinstein (D-Calif.), Patrick Leahy (D-Vt.), Chris Van Hollen (D-Md.), Joe Donnelly (D-Ind.), Kirsten Gillibrand (D-N.Y.) and Tammy Baldwin (D-Wis.).
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Grassley, Colleagues Urge DEA to Swiftly Issue Regulations and Guidance on Partial Fill Law to Better Address Nation’s Opioid Crisis
WASHINGTON – Sen. Chuck Grassley joined a bipartisan letter today urging the Drug Enforcement Administration (DEA) to update regulations and guidance related to the partial filling of Schedule II controlled substances. Doing so would give prescribers and pharmacists additional clarity about the new provisions of federal law and other steps that can be taken to better address the nation’s opioid crisis. The letter was penned by Sens. Elizabeth Warren (D-Mass.) and Shelley Moore Capito (R- W.Va.) and joined by Sens. Chuck Grassley (R-Iowa) and Dianne Feinstein (D-Calif.), Chairman and Ranking Member of the Senate Judiciary Committee, which has jurisdiction over the DEA. Reps. Katherine Clark (D-Mass.) and Steve Stivers (R-Ohio) also signed the letter.
More than 33,000 Americans died from opioid-related drug overdoses in 2015, and prescription painkillers continue to be a major contributor to the epidemic.
“Outdated DEA regulations, which include a different definition of ‘partial filling’ from the definition provided in CARA, have led to significant confusion on the part of pharmacists and prescribers,” wrote the Members of Congress. “These health care providers are critical partners in the fight against the opioid epidemic but are reluctant to move forward with implementation of the law or to proactively implement programs to partially fill initial opioid prescriptions until the DEA updates its regulations.”
According to the Substance Abuse and Mental Health Services Administration, more than 70 percent of people who misuse prescription painkillers got them from a friend, relative or doctor. Encouraging prescribers and pharmacists to embrace partial fill policies for their patients would help reduce the number of opioids that are misused in homes and communities across the country.
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Video & Audio: Grassley’s Christmas Message to Iowans
WASHINGTON – U.S. Sen. Chuck Grassley of Iowa delivered a Christmas message in a video address to Iowans.
“Christmas is a time to come together with family and friends, to celebrate the great blessings of life and the birth of our Lord and Savior. From my family to yours: Merry Christmas, happy holidays and a happy New Year,” Grassley said.
Click here for the full video.
Click here for the full audio (28 seconds).
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