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FDA Week - 05/18/2018

  • Trump's Idea Of Listing Prices In DTC Drug Ads Draws Swift Criticism

    Stakeholders are questioning the usefulness and feasibility of the White House's idea of requiring drug prices be disclosed in direct-to-consumer ads -- with some saying the idea would not survive a First Amendment challenge and others asserting including list prices could mislead consumers.

    913 words

  • Voluntary Restricted Distribution Used As Much As REMS To Slow Generics

    FDA's long-awaited list of brand drugs for which generics have sought the agency's help in obtaining the samples necessary for testing and approval confirms that Risk Evaluation and Mitigation Strategies are not the only tool used by brands to withhold samples. While REMS are the most-cited method, over half of the more than 50 drugs on the list unveiled Thursday (May 17) do not have a REMS -- demonstrating the effect so-called voluntary restricted distribution systems are having on generic competition.

    1067 words

  • House Appropriators Add Tobacco Measure To FDA Spending Bill

    The House Appropriations Committee approved Wednesday (May 16) a fiscal 2019 FDA spending bill, and in the process tacked on a controversial tobacco amendment that several Democrats and one Republican argued would essentially rewrite the Tobacco Control Act and weaken FDA's ability to regulate tobacco products, especially e-cigarettes and cigars that appeal to youth.

    1652 words

  • Gottlieb's Pressure Over Distribution Schemes Has Not Yielded Change

    FDA Commissioner Scott Gottlieb has fulfilled his promise to contact supply chain intermediaries and discourage them from entering into so-called voluntary restricted distribution systems that block generic companies from buying samples needed for FDA-required testing, however his pressure to date has not been successful.

    501 words

  • House To Vote On Senate-Passed Right To Try Bill Next Week

    The House will vote next week on the Right to Try bill passed out of the Senate last August, House leadership said Thursday. The move has the support of FDA Commissioner Scott Gottlieb, as well as House Energy & Commerce leadership, which previously argued the bill had problems that if not fixed would make the measure less effective for patients.

    555 words

  • Trump To USTR: Prioritize Drug IP, Market Access In Bid To Lower U.S. Prices

    President Donald Trump has directed U.S. Trade Representative Robert Lighthizer to ensure that intellectual property and market access policies in trade deals contribute to lower drug prices in the United States. HHS also discussed the issue in a request for information issued Monday (May 14) seeking stakeholders' feedback on myriad drug cost-containment ideas floated by the president.

    703 words

  • Azar Defends Drug Pricing Plan's Lack of Importation, Direct Negotiation

    HHS Secretary Alex Azar is explaining why the president's newly released drug pricing plan doesn't deliver on two of President Donald Trump's campaign promises: direct drug price negotiation in Medicare and allowing importation of cheaper drugs from Canada. Azar argued that both proposals were left out because they don't work, and while he dismissed importation outright, he argued that Trump's plan will actually increase price negotiation in Medicare, just not the way both Democrats and Trump had pushed.

    640 words

  • FDA Reviews Precision Drugs Faster, With Less Evidence Than Other Drugs

    Academic researchers found FDA has approved precision medicines 1.7 years faster on average than nonprecision medicine and with substantially less premarket evidence, which they cautioned could expose patients to unknown risks and uncertain benefits. While the decreased review time speeds up marketing and lowers development costs, it also necessitates waiting for years to collect postmarket data to glean potential adverse events, the researchers concluded in a May Health Affairs article.

    895 words

  • Gottlieb: Upcoming REMS Waiver Guidance Will Be 'Short'

    FDA Commissioner Scott Gottlieb said Tuesday (May 15) that the upcoming guidance on waiving the requirement that brands and generics share a safety system will be short and simply put brands on notice that FDA is ready, willing and able to waive the requirement when it is blocking generic competition -- despite an earlier prediction from a policy watcher close to the issue that the guidance would lay out specific steps each party must go through before FDA can waive the requirement.

    505 words

  • Gottlieb Broaches Real-World Impact Of Ad Disclosure Idea

    Facing a White House mandate to study whether FDA can require disclosure of drug list prices in direct-to-consumer ads, FDA Commissioner Scott Gottlieb insinuated it was an open question whether list prices are the best way to inform consumers of a drug's potential out-of-pocket cost. However, an agency spokesperson declined to say whether FDA will consider mandating disclosure of a different measure instead of list price.

    506 words

  • Gottlieb Points To CAR-T, Gene Therapies As Sources Of Market Competition

    FDA soon will announce a set of reforms intended to make the new drug approval process more efficient and spur innovation, FDA Commissioner Scott Gottlieb told reporters during a Monday (May 14) media briefing. The agency chief pointed to gene therapies that are therapeutically equivalent to each other as having the potential to increase competition and negotiating power when it comes to prices.

    477 words

  • Appropriators Want FDA To Study If TV Ad Warnings Affect Drug Adherence

    House appropriators added to their FDA spending bill Wednesday (May 16) a measure calling for FDA to analyze MedWatch data to see whether certain television advertisements -- specifically those from legal firms or marketing firms that warn consumers of dangers associated with specific medicines -- affect medication adherence.

    245 words

  • FDA Gives First Approval To Non-Opioid Treatment For Withdrawal

    FDA on Wednesday (May 16) approved US WorldMeds LLC's Lucemyra, the first agency-approved non-opioid treatment for mitigating the symptoms of opioid withdrawal. Lucemyra, FDA noted, is only approved for treatment up to 14 days and is to be used as part of a broader, long-term treatment plan for managing opioid use disorder. The agency also is requiring 15 additional postmarketing studies to assess longer-term use and use in children and newborns.

    491 words

  • HHS Eyes Ways To Revamp Rx Rebates, Azar Favors One Pharma Opposes

    HHS is weighing two opposing approaches for dealing with Medicare drug rebates -- doing away with rebates or making plans share them at the pharmacy counter -- and HHS Secretary Alex Azar seems to be leaning toward the former, which drug makers do not like.

    1148 words

  • Azar Hits Back At Pharma Criticism Of Drug-Price Containment Proposal

    HHS Secretary Alex Azar on Wednesday (May 16) hit back at the drug industry for criticizing the administration's proposal to move Medicare Part B drugs into Part D, and he said the announcement on how HHS will execute that policy is coming soon. He also warned that killing the administration's proposal will keep alive efforts to let the government negotiate prices.

    340 words

  • Much Of Trump's Plan Puts Onus On Patients To Get Cheaper Drugs

    Many of the policies in the president's drug price plan put the onus on patients to get cheaper drugs: such as including prices in drug ads, giving patients information on competing drug prices during office visits, posting drug prices on Medicare's "dashboard" website and banning gag orders that stop pharmacists from telling customers when it is cheaper to buy drugs without insurance. Other immediate actions weaken patient protections in Part D by letting plans limit coverage to one drug in each class and allowing for medication management in the six protected classes.

    757 words

  • Cummings Report Slams Trump For Not Embracing Drug Negotiation

    Rep. Elijah Cummings (D-MD), who met with President Donald Trump earlier in his presidency to push for Medicare price negotiation, appears to have given up on working with Trump -- releasing a report Friday (May 11) outlining what he sees as the president's failure to constrain drug prices.

    427 words

  • Wyden Seeks Documents On Novartis Payments To Cohen

    Senate Finance Committee ranking Democrat Ron Wyden (OR) is demanding documents about the $1.2 million that pharmaceutical company Novartis paid to Michael Cohen, President Donald Trump's personal lawyer, at the same time that the company was negotiating with federal officials over an expensive cancer therapy it developed.

    202 words

  • PhRMA Criticizes Several Policies In Trump's Drug-Cost Plan

    A Pharmaceutical Research and Manufacturers of America executive on Tuesday (May 15) criticized several policies that HHS is considering to lower drug costs: moving Medicare Part B drugs to Part D, replacing the Part B doctor-reimbursement system with the Competitive Acquisition Program, encouraging plans to restrict the use of drugs in protected classes, removing the two-drug per-class rule in Part D, basing Medicaid's average manufacturer price calculation on commercial-market net prices and removing the cap on price-inflation penalty in Medicaid.

    325 words

  • Democrats Hit Trump For Criticizing 340B While Backing Away From Rule

    Senate health committee ranking Democrat Patty Murray (WA) and Sen. Elizabeth Warren (D-MA) on Tuesday (May 15) criticized President Donald Trump for tying the 340B program to higher drug prices while his administration has repeatedly delayed implementation of a rule on ceiling prices and manufacturer penalties and pulled back guidance to clarify aspects of the program, including the definition of a 340B-eligible patient.

    1071 words

  • CMS Won't Cut Ratings For Plans That Manage Protected Rx Classes

    HHS Secretary Alex Azar said CMS will take a more permissive approach to the performance scores it gives drug plans that use medication management tools for drugs in Part D's six protected classes. The Obama administration was attacked by patients, drug makers and both political parties for proposing to remove the protected status of three of those drug classes, but Azar said the Trump administration's proposal would merely let plans take advantage of existing medication management tools that they fear employing. However, CMS is at least considering withdrawing protected status of drugs when companies raise prices aggressively, according to a request for information that CMS issued Monday (May 14).

    463 words

  • Impact Of Trump's Medicaid Drug-Price Ideas Hinges On Follow-Through

    Industry insiders and Medicaid experts are unsure how significantly President Donald Trump's drug-pricing plan will affect Medicaid drug prices, because it is not clear which of the Medicaid-related proposals CMS or Congress will seriously pursue. Many of the proposals are presented as options the administration may consider or as policy ideas on which the administration is seeking feedback through an HHS request for information.

    671 words

  • Trump Ties 340B To High Prices, Asks For Feedback On Changing Program

    President Donald Trump's drug price containment plan blames the 340B drug discount program in part for high drug prices, and asks for feedback in a number of areas including how the program's growth affects list prices and insurers, whether the definition of a 340B patient should be changed and how to better prohibit duplicate discounts.

    894 words

  • Consumer, Patient Advocates Tell Congress Not To Shrink 340B Program

    About 60 patient and consumer advocates told House and Senate leadership to reject proposals to cut back the number of patients and safety net providers that are eligible for the 340B drug discount program, though the groups say they support transparency in the program. The move comes as lawmakers in both chambers of Congress and the president call for changes to the program.

    260 words

  • CMS Opens National Coverage Analysis For CAR-T Cell Therapies

    CMS' Medicare Evidence Development & Coverage Advisory Committee will meet in August to consider a National Coverage Determination for chimeric antigen receptor (CAR)-T cell therapies after UnitedHealthcare requested such a determination to make sure there is a level playing field across Medicare for coverage of the expensive therapies.

    602 words

  • Part B Bargaining Is Azar's Top Priority In Rx Price Plan

    HHS Secretary Alex Azar said Monday (May 14) that HHS' proposal to subject Part B drugs to price negotiations in Part D is the most important piece of the president's plan to contain drug costs, and he said on Wednesday (May 16) that he will soon announce how he plans to execute that policy. CMS could move all Part B drugs into Part D, or it could test the proposal on just a few drugs, and drugs would be chosen for the demonstration based on either price or therapeutic substitutability.

    619 words