fbpx
Creed III, Only in Theaters, Get Tickets! Creed III, Only in Theaters, Get Tickets! Creed III, Only in Theaters, Get Tickets!
Friday, March 24, 2023
Mr. Glitterati
  • Automotive
    4 Common Mistakes To Avoid With Car Restorations

    4 Common Mistakes To Avoid With Car Restorations

    Signs That It Might Be Time To Get a New Car

    Signs That It Might Be Time To Get a New Car

    Mercedes-Benz Charging Network

    Mercedes-Benz to Launch Global Branded High-Power Charging Network in North America

    Ways To Surprise Your Partner Who Loves Cars

    Ways To Surprise Your Partner Who Loves Cars

    5 Important Tips for Every New Jeep Owner

    5 Important Tips for Every New Jeep Owner

    The Best Ways To Increase the Value of Your Car

    The Best Ways To Increase the Value of Your Car

    Why Jeeps Are Awesome for Off-Roading Adventures

    Why Jeeps Are Awesome for Off-Roading Adventures

    What To Know Before Purchasing Your First Motorcycle

    What To Know Before Purchasing Your First Motorcycle

    How To Ensure Proper Motorcycle Maintenance

    How To Ensure Proper Motorcycle Maintenance

    Trending Tags

    • Mercedes-Benz
    • Mustang
  • Business
    Fulfilling Side Hustles for Good Money in 2023

    Fulfilling Side Hustles for Good Money in 2023

    5 Tips on How To Run Your First Charity Event

    5 Tips on How To Run Your First Charity Event

    4 Ways To Prepare Yourself for a Big Promotion

    4 Ways To Prepare Yourself for a Big Promotion

    Tips for Setting Effective Goals for Your Business

    Tips for Setting Effective Goals for Your Business

    How To Host a Music Festival During Colder Months

    How To Host a Music Festival During Colder Months

    Tips for Designing an Effective Beverage Label

    Tips for Designing an Effective Beverage Label

    Delta now accepting flight attendant applications

    Delta now Accepting Flight Attendant Applications

    Common Mistakes That Every Manager Makes

    Common Mistakes That Every Manager Makes

    Important Safety Features in Commercial Buildings

    Important Safety Features in Commercial Buildings

    Trending Tags

    • Fashion
      Essential Tips for Planning a Great Fashion Show

      Essential Tips for Planning a Great Fashion Show

      Signs That Your Tuxedo Doesn’t Fit Right

      Signs That Your Tuxedo Doesn’t Fit Right

      Make a Bold Style Statement With These Wide-Leg Pants

      Make a Bold Style Statement With These Wide-Leg Pants

      Power Your Winter Workouts With The Best Zip Hoodies for Men

      Power Your Winter Workouts With The Best Zip Hoodies for Men

      The Ultimate Watch Buying Guide

      The Ultimate Watch Buying Guide

      Outdoor Enthusiasts, Take Note: These Watches Are as Tough as You

      Outdoor Enthusiasts, Take Note: These Watches Are as Tough as You

      Our 7 Favorite Field Jackets for Tackling Fall Weather

      Our 7 Favorite Field Jackets for Tackling Fall Weather

      The Best Leather Jackets for Guys – No Matter Your Budget

      The Best Leather Jackets for Guys – No Matter Your Budget

      Campus-Ready Backpacks for Storing *All* the Books

      Campus-Ready Backpacks for Storing *All* the Books

      Trending Tags

      • Food & Drink
        Cheese Tortellini in Creamy Marinara

        Cheese Tortellini in Creamy Marinara

        Unusual Products That Come From Animals and Their Uses

        Unusual Products That Come From Animals and Their Uses

        Tips for Creating a Homemade Wine Cellar

        Tips for Creating a Homemade Wine Cellar

        How the wine you choose can help you have an eco-friendly home

        How the Wine You Choose Can Help You have an Eco-Friendly Home

        Rum and Cola Holiday Ham

        Special Centerpieces for Holiday Celebrations

        ChefsGiving 2020

        This Holiday Season, How about Cooking for a Cause?

        Iced Cold Moscow Mule cocktail with lime and pomegranate

        Holiday Spirits: The Cranberry Smash Moscow Mule

        The Most Beautiful Liquor Bottles in the World

        The Most Beautiful Liquor Bottles in the World

        Tao Group Virtual Chef Experience

        Entertain Your Guests Virtually This Fall ?

        Trending Tags

        • Health
          When College Athletes Kill Themselves, Healing the Team Becomes the Next Goal

          When College Athletes Kill Themselves, Healing the Team Becomes the Next Goal

          The Policy, and Politics, of Medicare Advantage

          The Policy, and Politics, of Medicare Advantage

          Sen. Sanders Shows Fire, but Seeks Modest Goals, in His Debut Drug Hearing as Health Chair

          Sen. Sanders Shows Fire, but Seeks Modest Goals, in His Debut Drug Hearing as Health Chair

          Being ‘Socially Frail’ Comes With Health Risks for Older Adults

          Being ‘Socially Frail’ Comes With Health Risks for Older Adults

          Fresh Produce Is an Increasingly Popular Prescription for Chronically Ill Patients

          Fresh Produce Is an Increasingly Popular Prescription for Chronically Ill Patients

          End of Covid Emergency Will Usher in Changes Across the US Health System

          End of Covid Emergency Will Usher in Changes Across the US Health System

          Prescription for Housing? California Wants Medicaid to Cover 6 Months of Rent

          Prescription for Housing? California Wants Medicaid to Cover 6 Months of Rent

          Mental Health Care by Video Fills Gaps in Rural Nursing Homes

          Mental Health Care by Video Fills Gaps in Rural Nursing Homes

          Mobile Clinics Got Rolling in the Pandemic. A New Law Will Help Them Cast a Wider Safety Net.

          Mobile Clinics Got Rolling in the Pandemic. A New Law Will Help Them Cast a Wider Safety Net.

          Trending Tags

          • Lifestyle

            Sacrifice States: the US Nuclear Sponge

            woman with gun near thief at night in parking lot

            Why it’s Important to know Your 2nd Amendment Rights

            Tips for Growing a Fuller and Healthier Beard

            Tips for Growing a Fuller and Healthier Beard

            Fulfilling Side Hustles for Good Money in 2023

            Fulfilling Side Hustles for Good Money in 2023

            5 Tips on How To Run Your First Charity Event

            5 Tips on How To Run Your First Charity Event

            Essential Home Defense Gear for Gun Owners

            Essential Home Defense Gear for Gun Owners

            Lake Mead Nevada

            The Ramifications of Lake Mead Drying Up

            Different Types of Lucrative Collectibles To Invest In

            Different Types of Lucrative Collectibles To Invest In

            Long, Lush, Lovely: Styling & Care Tips for Long-Haired Men

            Long, Lush, Lovely: Styling & Care Tips for Long-Haired Men

            Trending Tags

            • Politics
              Collapsed Silicon Valley Bank enlisted ‘revolving door’ lobbyists to push its policy agenda in Washington

              Collapsed Silicon Valley Bank enlisted ‘revolving door’ lobbyists to push its policy agenda in Washington

              Candidates spend a record amount of campaign funds on childcare in 2022 midterms

              Candidates spend a record amount of campaign funds on childcare in 2022 midterms

              March Madness 2023: Annual K Street College Classic bracket features biggest federal lobbying spenders in higher education

              March Madness 2023: Annual K Street College Classic bracket features biggest federal lobbying spenders in higher education

              ‘Pop-up’ super PACs poured millions into high-stakes congressional races without disclosing their donors ahead of the 2022 general election

              ‘Pop-up’ super PACs poured millions into high-stakes congressional races without disclosing their donors ahead of the 2022 general election

              Sunshine Week: Shining a light on money in politics

              Sunshine Week: Shining a light on money in politics

              Wisconsin’s high-stakes, high-spending Supreme Court elections

              Wisconsin’s high-stakes, high-spending Supreme Court elections

              Armed Services Committee members received $5.8 million from defense sector during 2022 election cycle

              Armed Services Committee members received $5.8 million from defense sector during 2022 election cycle

              Senate Banking Committee presses Federal Reserve chair on capital requirements following big bank lobbying blitz

              Senate Banking Committee presses Federal Reserve chair on capital requirements following big bank lobbying blitz

              New federal indictment sheds light on former FTX CEO Sam Bankman-Fried’s alleged straw donor scheme

              New federal indictment sheds light on former FTX CEO Sam Bankman-Fried’s alleged straw donor scheme

              Trending Tags

              • Real Estate
                How To Make Your Rental Property More Eco-Friendly

                How To Make Your Rental Property More Eco-Friendly

                Things To Consider Before Investing in Real Estate Overseas

                Things To Consider Before Investing in Real Estate Overseas

                Incredible Areas in Florida To Buy a Vacation Home

                Incredible Areas in Florida To Buy a Vacation Home

                Helpful Home Staging Tips for Virtual Tours

                Helpful Home Staging Tips for Virtual Tours

                Ways To Decorate and Design a Lake House

                Ways To Decorate and Design a Lake House

                Challenges To Managing a Rental Property

                Challenges To Managing a Rental Property

                The Best Landlord: How To Show Tenants You Care

                The Best Landlord: How To Show Tenants You Care

                The Best Locations To Invest in a Second Home

                The Best Locations To Invest in a Second Home

                How a Nice Garden Can Impress Buyers

                How a Nice Garden Can Impress Buyers

                Trending Tags

                • More…
                  • Sports
                  • Technology
                  • Travel
                No Result
                View All Result
                • Automotive
                  4 Common Mistakes To Avoid With Car Restorations

                  4 Common Mistakes To Avoid With Car Restorations

                  Signs That It Might Be Time To Get a New Car

                  Signs That It Might Be Time To Get a New Car

                  Mercedes-Benz Charging Network

                  Mercedes-Benz to Launch Global Branded High-Power Charging Network in North America

                  Ways To Surprise Your Partner Who Loves Cars

                  Ways To Surprise Your Partner Who Loves Cars

                  5 Important Tips for Every New Jeep Owner

                  5 Important Tips for Every New Jeep Owner

                  The Best Ways To Increase the Value of Your Car

                  The Best Ways To Increase the Value of Your Car

                  Why Jeeps Are Awesome for Off-Roading Adventures

                  Why Jeeps Are Awesome for Off-Roading Adventures

                  What To Know Before Purchasing Your First Motorcycle

                  What To Know Before Purchasing Your First Motorcycle

                  How To Ensure Proper Motorcycle Maintenance

                  How To Ensure Proper Motorcycle Maintenance

                  Trending Tags

                  • Mercedes-Benz
                  • Mustang
                • Business
                  Fulfilling Side Hustles for Good Money in 2023

                  Fulfilling Side Hustles for Good Money in 2023

                  5 Tips on How To Run Your First Charity Event

                  5 Tips on How To Run Your First Charity Event

                  4 Ways To Prepare Yourself for a Big Promotion

                  4 Ways To Prepare Yourself for a Big Promotion

                  Tips for Setting Effective Goals for Your Business

                  Tips for Setting Effective Goals for Your Business

                  How To Host a Music Festival During Colder Months

                  How To Host a Music Festival During Colder Months

                  Tips for Designing an Effective Beverage Label

                  Tips for Designing an Effective Beverage Label

                  Delta now accepting flight attendant applications

                  Delta now Accepting Flight Attendant Applications

                  Common Mistakes That Every Manager Makes

                  Common Mistakes That Every Manager Makes

                  Important Safety Features in Commercial Buildings

                  Important Safety Features in Commercial Buildings

                  Trending Tags

                  • Fashion
                    Essential Tips for Planning a Great Fashion Show

                    Essential Tips for Planning a Great Fashion Show

                    Signs That Your Tuxedo Doesn’t Fit Right

                    Signs That Your Tuxedo Doesn’t Fit Right

                    Make a Bold Style Statement With These Wide-Leg Pants

                    Make a Bold Style Statement With These Wide-Leg Pants

                    Power Your Winter Workouts With The Best Zip Hoodies for Men

                    Power Your Winter Workouts With The Best Zip Hoodies for Men

                    The Ultimate Watch Buying Guide

                    The Ultimate Watch Buying Guide

                    Outdoor Enthusiasts, Take Note: These Watches Are as Tough as You

                    Outdoor Enthusiasts, Take Note: These Watches Are as Tough as You

                    Our 7 Favorite Field Jackets for Tackling Fall Weather

                    Our 7 Favorite Field Jackets for Tackling Fall Weather

                    The Best Leather Jackets for Guys – No Matter Your Budget

                    The Best Leather Jackets for Guys – No Matter Your Budget

                    Campus-Ready Backpacks for Storing *All* the Books

                    Campus-Ready Backpacks for Storing *All* the Books

                    Trending Tags

                    • Food & Drink
                      Cheese Tortellini in Creamy Marinara

                      Cheese Tortellini in Creamy Marinara

                      Unusual Products That Come From Animals and Their Uses

                      Unusual Products That Come From Animals and Their Uses

                      Tips for Creating a Homemade Wine Cellar

                      Tips for Creating a Homemade Wine Cellar

                      How the wine you choose can help you have an eco-friendly home

                      How the Wine You Choose Can Help You have an Eco-Friendly Home

                      Rum and Cola Holiday Ham

                      Special Centerpieces for Holiday Celebrations

                      ChefsGiving 2020

                      This Holiday Season, How about Cooking for a Cause?

                      Iced Cold Moscow Mule cocktail with lime and pomegranate

                      Holiday Spirits: The Cranberry Smash Moscow Mule

                      The Most Beautiful Liquor Bottles in the World

                      The Most Beautiful Liquor Bottles in the World

                      Tao Group Virtual Chef Experience

                      Entertain Your Guests Virtually This Fall ?

                      Trending Tags

                      • Health
                        When College Athletes Kill Themselves, Healing the Team Becomes the Next Goal

                        When College Athletes Kill Themselves, Healing the Team Becomes the Next Goal

                        The Policy, and Politics, of Medicare Advantage

                        The Policy, and Politics, of Medicare Advantage

                        Sen. Sanders Shows Fire, but Seeks Modest Goals, in His Debut Drug Hearing as Health Chair

                        Sen. Sanders Shows Fire, but Seeks Modest Goals, in His Debut Drug Hearing as Health Chair

                        Being ‘Socially Frail’ Comes With Health Risks for Older Adults

                        Being ‘Socially Frail’ Comes With Health Risks for Older Adults

                        Fresh Produce Is an Increasingly Popular Prescription for Chronically Ill Patients

                        Fresh Produce Is an Increasingly Popular Prescription for Chronically Ill Patients

                        End of Covid Emergency Will Usher in Changes Across the US Health System

                        End of Covid Emergency Will Usher in Changes Across the US Health System

                        Prescription for Housing? California Wants Medicaid to Cover 6 Months of Rent

                        Prescription for Housing? California Wants Medicaid to Cover 6 Months of Rent

                        Mental Health Care by Video Fills Gaps in Rural Nursing Homes

                        Mental Health Care by Video Fills Gaps in Rural Nursing Homes

                        Mobile Clinics Got Rolling in the Pandemic. A New Law Will Help Them Cast a Wider Safety Net.

                        Mobile Clinics Got Rolling in the Pandemic. A New Law Will Help Them Cast a Wider Safety Net.

                        Trending Tags

                        • Lifestyle

                          Sacrifice States: the US Nuclear Sponge

                          woman with gun near thief at night in parking lot

                          Why it’s Important to know Your 2nd Amendment Rights

                          Tips for Growing a Fuller and Healthier Beard

                          Tips for Growing a Fuller and Healthier Beard

                          Fulfilling Side Hustles for Good Money in 2023

                          Fulfilling Side Hustles for Good Money in 2023

                          5 Tips on How To Run Your First Charity Event

                          5 Tips on How To Run Your First Charity Event

                          Essential Home Defense Gear for Gun Owners

                          Essential Home Defense Gear for Gun Owners

                          Lake Mead Nevada

                          The Ramifications of Lake Mead Drying Up

                          Different Types of Lucrative Collectibles To Invest In

                          Different Types of Lucrative Collectibles To Invest In

                          Long, Lush, Lovely: Styling & Care Tips for Long-Haired Men

                          Long, Lush, Lovely: Styling & Care Tips for Long-Haired Men

                          Trending Tags

                          • Politics
                            Collapsed Silicon Valley Bank enlisted ‘revolving door’ lobbyists to push its policy agenda in Washington

                            Collapsed Silicon Valley Bank enlisted ‘revolving door’ lobbyists to push its policy agenda in Washington

                            Candidates spend a record amount of campaign funds on childcare in 2022 midterms

                            Candidates spend a record amount of campaign funds on childcare in 2022 midterms

                            March Madness 2023: Annual K Street College Classic bracket features biggest federal lobbying spenders in higher education

                            March Madness 2023: Annual K Street College Classic bracket features biggest federal lobbying spenders in higher education

                            ‘Pop-up’ super PACs poured millions into high-stakes congressional races without disclosing their donors ahead of the 2022 general election

                            ‘Pop-up’ super PACs poured millions into high-stakes congressional races without disclosing their donors ahead of the 2022 general election

                            Sunshine Week: Shining a light on money in politics

                            Sunshine Week: Shining a light on money in politics

                            Wisconsin’s high-stakes, high-spending Supreme Court elections

                            Wisconsin’s high-stakes, high-spending Supreme Court elections

                            Armed Services Committee members received $5.8 million from defense sector during 2022 election cycle

                            Armed Services Committee members received $5.8 million from defense sector during 2022 election cycle

                            Senate Banking Committee presses Federal Reserve chair on capital requirements following big bank lobbying blitz

                            Senate Banking Committee presses Federal Reserve chair on capital requirements following big bank lobbying blitz

                            New federal indictment sheds light on former FTX CEO Sam Bankman-Fried’s alleged straw donor scheme

                            New federal indictment sheds light on former FTX CEO Sam Bankman-Fried’s alleged straw donor scheme

                            Trending Tags

                            • Real Estate
                              How To Make Your Rental Property More Eco-Friendly

                              How To Make Your Rental Property More Eco-Friendly

                              Things To Consider Before Investing in Real Estate Overseas

                              Things To Consider Before Investing in Real Estate Overseas

                              Incredible Areas in Florida To Buy a Vacation Home

                              Incredible Areas in Florida To Buy a Vacation Home

                              Helpful Home Staging Tips for Virtual Tours

                              Helpful Home Staging Tips for Virtual Tours

                              Ways To Decorate and Design a Lake House

                              Ways To Decorate and Design a Lake House

                              Challenges To Managing a Rental Property

                              Challenges To Managing a Rental Property

                              The Best Landlord: How To Show Tenants You Care

                              The Best Landlord: How To Show Tenants You Care

                              The Best Locations To Invest in a Second Home

                              The Best Locations To Invest in a Second Home

                              How a Nice Garden Can Impress Buyers

                              How a Nice Garden Can Impress Buyers

                              Trending Tags

                              • More…
                                • Sports
                                • Technology
                                • Travel
                              No Result
                              View All Result
                              Mr. Glitterati
                              No Result
                              View All Result

                              A Bitter Battle Over the ‘Orphan Drug’ Program Leaves Patients’ Pocketbooks at Risk

                              by Staff Writer
                              February 22, 2023
                              in Health
                              A Bitter Battle Over the ‘Orphan Drug’ Program Leaves Patients’ Pocketbooks at Risk
                              0
                              SHARES
                              82
                              VIEWS

                              By Sarah Jane Tribble

                              A prescription drug that helps Lore Wilkinson walk and talk despite a rare muscle disease cost her so little for more than a decade that she didn’t even use her insurance to pay for it. But now, her Medicare insurance is shelling out about $40,000 for a one-month supply of the drug, and she fears she’ll be slammed with a $9,000 copayment.

                              “Who can afford that?” said the 91-year-old, who lives in Rochester, Minnesota. (Her first name is pronounced LOR-ee.)

                              Wilkinson, like millions of other people with rare diseases nationwide, is caught up in an ongoing legal and political debate about how the U.S. supports pharmaceutical companies and their research. The FDA made its latest move in the tug of war in late January by saying it would largely ignore a U.S. court ruling involving Firdapse, the drug Wilkinson needs.

                              Firdapse was approved in 2018 by the FDA as an “orphan drug,” a designation that rewards drug companies for developing treatments for rare diseases. When a drugmaker wins approval for an orphan drug, the company is entitled to seven years of exclusive rights to the marketplace, which means the FDA won’t approve another company’s application for a competitive drug for the same use during that period.

                              But after the 11th U.S. Circuit Court of Appeals denied a motion in early 2022, the FDA stopped reviewing applications for certain drugs or handing out exclusivity, agency spokesperson April Grant said. The delay left drugmakers in limbo.

                              Often, drugs granted exclusivity are among the highest priced in the U.S. market. For example, Zolgensma, a one-time treatment for spinal muscular atrophy, carries a $2.25 million price tag. Mary Carmichael, a spokesperson for its manufacturer, Novartis, said Zolgensma has treated more than 3,000 patients globally and nearly all U.S. patients taking the drug as approved by the FDA are covered by commercial or government insurance.

                              The company also continues to invest in research and development as well as clinical studies for the drug to reach more patients, Carmichael said. Most drugs enter the U.S. market armed with a variety of patents and intellectual property protections that stave off competition and allow drugmakers to set prices as they see fit. For drugs that treat rare diseases, the seven years of market exclusivity is part of that armor.

                              A year’s supply of Catalyst Pharmaceuticals’ Firdapse, which Wilkinson takes to treat her Lambert-Eaton myasthenic syndrome, or LEMS, sells for about $375,000 after discounts, said Catalyst spokesperson David Schull. He said the company has financial assistance programs and donates to charitable foundations to help those in need. The goal, Schull said, “is that no LEMS patient is ever denied access to medication for financial reasons.”

                              Catalyst was granted exclusive market rights for Firdapse in 2018, which meant that Wilkinson and other LEMS patients could no longer get a similar drug from another company free of charge.

                              In 2019, amid a patient uproar about the cost, which Sen. Bernie Sanders weighed in on, the FDA granted another company, Jacobus Pharmaceutical, the right to market a competitive product for a subset of pediatric patients.

                              Then Catalyst filed suit against the federal government, contending it had rights to be the exclusive provider for all LEMS patients, regardless of age. The case, Catalyst Pharmaceuticals Inc. v. Becerra, had potentially “far-reaching implications,” wrote Grant, the FDA spokesperson, in an email to KHN. The court’s decision also “raised several novel questions,” she said.

                              The 11th Circuit sided with Catalyst in September 2021. But the FDA’s recent move to effectively disregard the court’s decision is “in the best interest of public health, rare disease patients and rare disease product development,” Grant wrote.

                              Still, the multiyear saga highlights lingering questions about orphan drug exclusivity and how the FDA’s policies may influence drug prices. At issue is the Orphan Drug Act, a 1980s-era law that incentivizes drug companies to research and develop rare-disease drugs. And it’s not the first time the orphan drug program has raised concerns.

                              For decades, the FDA has overseen a two-step process: A drug is first granted an orphan designation because it shows promise to treat a rare disease or condition. Then, once the pharmaceutical company studies and develops the rare-disease drug, the FDA approves its use and awards seven-year market exclusivity, preventing competition.

                              That final step, granting exclusivity, was in the spotlight in Catalyst’s lawsuit against the FDA. Since the Orphan Drug Act was created, the FDA’s staff routinely handed out exclusivity to companies for orphan drugs that treat a subset of patients, such as pediatrics. The goal was to make sure pharmaceutical companies didn’t get total market control for a drug after doing studies on only the “smallest, easiest-to-study populations,” the agency wrote on its website.

                              The Catalyst court decision could hurt children, agency officials wrote.

                              George O’Brien, a partner at Mayer Brown who represents companies regarding the FDA and regulatory practices, said he agreed with the FDA’s decision and its long-term strategy of parceling out exclusivity because a drug’s sales “should be limited to what you studied and got approved.”

                              “Most people think the way the FDA has done it for years is a very sensible way to do it,” O’Brien said. “Good for patients, good for pharma, and good for the FDA.”

                              The FDA said that it will comply with the court’s decision regarding Catalyst but that it doesn’t apply to other companies or drugs. In response to the FDA’s January announcement, Catalyst said it would not be affected. In July 2022, Catalyst bought the rights to Ruzurgi, the Jacobus drug.

                              Now, there is no competitive drug on the market that treats Wilkinson’s disease.

                              Jacobus had provided Wilkinson with the active ingredient of its drug free of charge from 2004 to 2018: “The only thing I paid was shipping.”

                              The FDA’s move to largely rebuke the Catalyst case will likely mean another company will sue the agency again, O’Brien said: “They are in a really tough spot.”

                              “My worry is there is just another lawsuit coming. And its uncertainty. Uncertainty is ultimately bad for patients,” O’Brien said.

                              Drugmakers have taken the FDA to court before over how the agency administers the Orphan Drug Act. In 2014, Depomed won a suit against the agency demanding an exclusivity label on its drug Gralise, which treated nerve pain.

                              The FDA had given Gralise an orphan designation and approval but declined to give it exclusivity because it said it was not clinically superior to another drug already on the market. Then-federal district court judge Kentaji Brown Jackson, who was appointed to the U.S. Supreme Court last year, required the FDA to grant exclusivity, blocking a generic.

                              That case was focused on the clinical superiority of a drug, rather than the scope of exclusivity. After the Gralise decision, the FDA eventually persuaded Congress to amend the law, which may be needed now, O’Brien said. Rachel Sher, a former director of policy at the National Organization for Rare Disorders who is now at Manatt, Phelps, & Phillips, said companies that would benefit from a broader award of exclusivity will sue to force the agency for the same reading of the Orphan Drug Act.

                              “Congress will need to act at some point,” said Sher, who also spent a decade on Capitol Hill as the FDA counsel for the House Energy and Commerce Committee.

                              Congress almost passed an amendment last year when it reauthorized the user fees that help fund the FDA. Then-Sen. Richard Burr (R-N.C.) argued to take the committee-added amendment out of the package, saying drugmakers would otherwise lack the incentives needed to develop drugs for rare diseases, according to Bloomberg Law.

                              Wilkinson, the patient advocate, has her own advice for Congress. The Orphan Drug Act itself — not just the exclusivity provision — needs to be fixed, she said.

                              “They have to change the law,” she said. Pharmaceutical companies should only win orphan drug status and be given exclusivity when they develop “a really new medication, not just by changing one molecule.”

                              Until then, Wilkinson said, she and others are still waiting: “I’m an old lady, and I don’t know if it is going to get fixed.”

                              This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

                              KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

                              USE OUR CONTENT

                              This story can be republished for free (details).

                              source

                              Tags: HealthcareHealthy LivingPublic Health
                              Previous Post

                              Understanding the Difference between Patriotism and Nationalism

                              Next Post

                              In Tennessee, a Medicaid Mix-Up Might Land You on a ‘Most Wanted’ List

                              Next Post
                              In Tennessee, a Medicaid Mix-Up Might Land You on a ‘Most Wanted’ List

                              In Tennessee, a Medicaid Mix-Up Might Land You on a ‘Most Wanted’ List

                              Subscribe
                              Connect with
                              Notify of
                              guest
                              guest
                              0 Comments
                              Inline Feedbacks
                              View all comments

                              Recommended

                              How To Increase Your Boat’s Value

                              How To Increase Your Boat’s Value

                              2 years ago
                              Best Ideas for Storing Your Car for the Winter

                              Best Ideas for Storing Your Car for the Winter

                              1 year ago

                              Popular News

                              • The Best Colors If You Want To Buy a Sports Car

                                The Best Colors If You Want To Buy a Sports Car

                                1 shares
                                Share 0 Tweet 0
                              • The Top 5 Best States To Learn To Fly In

                                1 shares
                                Share 0 Tweet 0
                              • 7 of the Top Most Iconic Classic Car Colors

                                1 shares
                                Share 0 Tweet 0
                              • Generic vs. Name-Brand Clothes: Which Should You Pick?

                                1 shares
                                Share 0 Tweet 0
                              • The Sky Casino at Encore Las Vegas

                                0 shares
                                Share 0 Tweet 0

                              Connect with Us!

                              Categories

                              • Automotive
                              • Boating
                              • Business
                              • Coronavirus
                              • Entertainment
                              • Fashion
                              • Food & Drink
                              • Health
                              • Home and Garden
                              • Interview
                              • Legal
                              • Lifestyle
                              • Outdoors
                              • Politics
                              • Real Estate
                              • Sports
                              • Technology
                              • Travel

                              Contributors

                              • Grant Veil
                              • Jennifer Edwards
                              • Ron “Mr. Glitterati” Jones
                              • Steven Klimaski
                              • Staff Writers

                              User Links

                              • Login
                              • Register

                              Newsletter

                              Sign up and never miss a thing!.

                              SUBSCRIBE

                              • Contact
                              • Privacy
                              • Legal
                              • Cookies
                              • Affirm
                              • Refunds
                              • Shipping
                              • Terms
                              • Policies

                              © 2008 - 2023 Mr. Glitterati LLC - Unbiased News and Media.

                              No Result
                              View All Result
                              • Home
                              • Politics
                              • Business
                              • Entertainment
                              • Sports
                              • Fashion
                              • Lifestyle
                              • Travel
                              • Health
                              • Login
                              • Sign Up
                              • Cart

                              © 2008 - 2023 Mr. Glitterati LLC - Unbiased News and Media.

                              Welcome Back!

                              Sign In with Facebook
                              Sign In with Google
                              Sign In with Linked In
                              OR

                              Login to your account below

                              Forgotten Password? Sign Up

                              Create New Account!

                              Fill the forms below to register

                              All fields are required. Log In

                              Retrieve your password

                              Please enter your username or email address to reset your password.

                              Log In

                              Add New Playlist

                              wpDiscuz
                              0
                              0
                              Would love your thoughts, please comment.x
                              ()
                              x
                              | Reply