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Rx Drugs

July 18, 2019 | Daily News

House Republicans want FDA to expand the Parallel Track pathway, which currently provides patients with HIV and AIDS drugs that have not been FDA approved but are being studied in clinical trials, to include potential therapies for debilitating diseases such as Alzheimer’s and cancer.

July 18, 2019 | Daily News

FDA took another step to help speed up access to generic drugs by publishing draft guidance that explains how drug makers can better use the Inactive Ingredient Database (IID) in drug development, including to evaluate the safety of inactive ingredients, also known as excipients.

July 18, 2019 | Daily News

Reckitt Benckiser Group, which used to own Suboxone maker Indivior, has agreed to pay $700 million to the federal government and $50 million to settle Federal Trade Commissioner charges that the company violated antitrust laws in an attempt to thwart generic competition to the opioid addiction treatment drug Suboxone.

July 18, 2019 | Daily News

Free-market think-tank Pacific Research Institute released a report Thursday (July 11) that pinpoints market practices -- such as low biosimilar reimbursement, step therapy policies and anti-competitive contracting practices -- and lack of education from FDA on interchangeability and biosimilar safety as the biggest obstacles to biosimilar competition.

July 17, 2019 | Daily News

The Treasury Department on Wednesday (July 17) issued guidance listing 14 preventive drugs and services used for common chronic conditions -- including insulin, statins and beta-blockers -- that now can be covered pre-deductible by health plans linked to health savings accounts (HSAs), responding quickly to President Trump’s June 24 executive order that directed the department explore the change.

July 16, 2019 | Daily News

Senate Republicans tried to quickly move the health committee’s broad legislative package through the floor via a procedural move but hit a snag when several senators objected due to concerns over the surprise billing provisions, according to lawmakers -- signaling that the legislation likely won’t be easily passed like lawmakers originally predicted.

July 16, 2019 | Daily News

Senate Republican leadership hotlined the health committee’s broad cost-cutting package in order to ascertain GOP concerns and discovered several senators were prepared to hold up floor action over the surprise billing provisions -- signaling that Senate leaders have work cut out for them before they can move broader legislation that is expected to merge the health committee's bill with drug-pricing measures from the Finance and Judiciary committees.

July 16, 2019 | Daily News

The Congressional Budget Office on Tuesday (July 16) reported that the wide-ranging Senate health committee bill, which aims to end surprise medical billing, increase transparency and lower prescription drug and other health costs, would save about $7.6 billion over 10 years, largely due to expected decreases in federal spending on insurance premiums as a result of the surprise billing provisions.

July 16, 2019 | Daily News

Sen. Kamala Harris is the latest Democratic presidential candidate to vow that Americans would not pay more for drugs than other countries pay, if she is elected.

July 16, 2019 | Daily News

Lawmakers and federal agencies tasked with monitoring illicit drug flow, including FDA and Customs and Border Protection, pinpointed a lack of data sharing among agencies as a challenge in combating the illicit flow of fentanyl into the United States.

July 16, 2019 | Daily News

Nearly all the Democratic members of the Senate Finance Committee asked ranking Democrat Sen. Ron Wyden (OR) to push for government price negotiation authority to be included in the committee’s drug-pricing package.

July 15, 2019 | Daily News

Democratic presidential candidate Sen. Amy Klobuchar (D-MN) released a plan for seniors on Friday (July 12) that includes a number of Medicare proposals, including expanding Medicare services for Alzheimer’s patients, supporting site-neutral payments and expanding telehealth, as other presidential hopefuls begin to release their own health plans.

July 15, 2019 | Daily News

The National Institutes of Health (NIH) will conduct a phase III HIV vaccine efficacy trial at multiple clinical research sites in North America, South America and Europe, the agency announced Monday (July 15).

July 15, 2019 | Daily News

Democratic presidential candidate Joe Biden over the weekend added himself to the list of Democrats pushing for Medicare drug price negotiation, and his plan includes a foreign-price component that takes a page from President Donald Trump’s plan to tie Medicare Part B drugs to foreign prices.

July 15, 2019 | Daily News

FDA lays out how to establish the safety and efficacy of birth control medicines, including oral contraceptives, long-acting injectables and intrauterine systems (IUSs), in draft guidance published Thursday (July 11).

July 12, 2019 | Daily News

CMS is working on possible changes to the end stage renal disease pay system as part of a broader kidney care revamp unveiled by HHS Wednesday (July 10), as the agency says that “continual refinement of the ESRD PPS is necessary to benefit people living with ESRD.”

July 12, 2019 | Daily News

HHS Secretary Alex Azar said Thursday (July 11) that it is possible to safely import prescription drugs because the supply channel has changed substantially since Congress first passed drug importation legislation during the Clinton administration.

July 11, 2019 | Daily News

House Speaker Nancy Pelosi (D-CA) is negotiating with the White House on a government drug price negotiation plan that spans Medicare Part D, Part B and Medicaid, and the Federal Trade Commission or the Veterans Health Administration would arbitrate when HHS officials and drug company executives fail to agree on price, according to sources briefed on the latest proposal.

July 11, 2019 | Daily News

Drug companies and consumer advocates applauded the United Kingdom health department’s decision to test a first-of-its-kind subscription-style model that pays drug companies upfront for new antibiotics based on their usefulness to the U.K’s single-payer health system.

July 11, 2019 | Daily News

SAN DIEGO -- FDA officials recently emphasized that drug pricing, while an important topic, is one that they generally can’t address as part of the regulatory process due to statutory restrictions.

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