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Rx Drugs

October 25, 2018 | Daily News

The brand pharmaceutical industry came out swinging against the Trump administration's newly unveiled plan to use an international pricing index to pay for physician-administered drugs in Medicare, likening the idea to price controls imposed by foreign countries with socialized health care.

October 25, 2018 | Daily News

In a new report released Thursday (Oct. 25), the White House Council of Economic Advisers touts FDA’s efforts to drive down drug prices by ramping up drug approvals and increasing competition on the marketplace, pointing to both generic and brand drug approvals.

October 25, 2018 | Daily News

Medicare pays double what other developed countries pay for Part B drugs, according to a report released by the administration hours before President Donald Trump is slated to deliver a speech on drug prices.

October 25, 2018 | Daily News

FDA on Wednesday (Oct. 24) released a draft guidance aimed at clarifying what systems drug companies must have in place to comply with legal requirements regarding the quarantine and investigation of suspect drugs, as well as the quarantine and disposal of illegitimate drugs.

October 25, 2018 |

Democratic Sens. Elizabeth Warren (MA) and Tina Smith (MN) are asking HHS Secretary Alex Azar to provide additional information in support of his allegations in congressional testimony this summer that drug-channel middlemen are thwarting drug company efforts to lower list prices.

October 24, 2018 | Daily News

Amgen announced it is cutting the list price of its cholesterol drug Repatha by 60 percent a day before President Donald Trump is expected to give a speech about drug prices, and a company press release said the price cut “reflects Amgen’s support for the goal of President Trump and his Administration to lower the price of drugs for U.S. consumers.”

October 24, 2018 | Daily News

President Donald Trump will give a speech Thursday (Oct. 25) that is widely expected to be at least in part about drug prices, sources say, though it isn't clear whether he will announce new policies or tout measures the administration has already taken to curb the rise of drug prices.

October 24, 2018 | Daily News

FDA Commissioner Scott Gottlieb expressed concern that, in the bid to bring to market more drugs that address unmet medical needs, the medical product development and regulatory space has lost focus on developing drugs for more common illnesses.

October 23, 2018 | Daily News

Although President Donald Trump has pledged to make drug companies bid for government business, the White House Council of Economic Advisers said Tuesday (Oct. 23) that Medicare negotiation of drug prices would significantly curtail the invention of new pharmaceuticals.

October 23, 2018 | Daily News

A White House official said the administration needs to make sure no regulations or policies get in the way of insurers shifting to a new value-based model where payments are made over time for new, expensive curative treatments and refunds are obtained if the treatments stop working.

October 23, 2018 | Daily News

FDA will ask two of its advisory committees to weigh in on expanding the availability of naloxone for use in the community during a two-day meeting Dec. 17 and 18, the agency announced Tuesday (Oct. 23).

October 23, 2018 | Daily News

The head of FDA's anesthetic and analgesic advisory committee has joined consumer group Public Citizen in urging FDA to reject approval of AcelRx's DSUVIA, a sufentanil sublingual drug-device combination tablet that is five to 10 times more potent than fentanyl.

October 23, 2018 | Daily News

A bipartisan bill aimed at making it easier for Medicare Advantage and Medicare drug plans to enter into so-called value-based pay contracts is expected to be introduced as early as next week, according to Council for Affordable Health Coverage President Joel White.

October 23, 2018 | Daily News

Maryland Attorney General Brian Frosh asked the Supreme Court to review the state’s law that would give its attorney general authority to sue generic drug manufacturers for “unconscionable” drug price increases, after a Fourth Circuit panel stopped the law from going into effect.

October 22, 2018 | Daily News

Colorado will soon ask CMS for permission to use outcomes-based prescription drug contracts in its Medicaid program, a state health official told Inside Health Policy Tuesday (Oct. 16).

October 19, 2018 | Daily News

HHS told a federal court that it intends to release by Nov. 1 a proposal that would move the effective date for the 340B ceiling prices and penalties rule to Jan. 1, up from July 1, and for that reason the court should put a lawsuit over the date on hold.

October 18, 2018 | Daily News

Legal experts point to what they view as flaws in FDA's recently announced plan to alert the Federal Trade Commission (FTC) when brand-drug makers use the citizen petition process to delay generics from entering the market.

October 17, 2018 | Daily News

FDA plans to finalize in mid-2019 its nearly decade-old proposed rule mandating that direct-to-consumer prescription drug advertisements state the drug’s major side effects and risks in a “clear, conspicuous, and neutral manner,” according to the agency’s fall 2018 regulatory agenda released Tuesday (Oct. 16).

October 17, 2018 | Daily News

Two rules that are expected to include major policies to curb drug prices are scheduled to be released this month, according to the fall regulatory agenda. However, the agenda’s timetable is often wrong.

October 17, 2018 | Daily News

A U.S. Patent and Trademark Office decision to align standards in its administrative patent appeals court with those of district courts will soon give generic drug and biosimilar producers fewer options to challenge patents.

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