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Rx Drugs

October 27, 2017 | Daily News

As FDA rethinks some of its Risk Evaluation and Mitigation Strategies (REMS) requirements on opioid manufacturers, some attorneys, including a former FDA chief counsel, agree the agency could consider including a take-back program as part of the restrictions, despite what's seen as inevitable pushback from industry.

October 27, 2017 | Daily News

CMS officials on Thursday (Oct. 26) met with pharmaceutical and insurance company representatives to discuss movement toward value-based payment, including how to measure value and quality, CMS Administrator Seema Verma said.

October 27, 2017 | Daily News

House Energy & Commerce ranking Democrat Frank Pallone (NJ) is urging the International Trade Commission not to take up a first-of-its-kind lawsuit filed by Amarin Pharmaceuticals to block importation and essentially freeze U.S. inventory of certain synthetic omega-3 products being sold as dietary supplements.

October 27, 2017 | Daily News

Endo Pharmaceuticals and subsidy Par Sterile Products are suing FDA to block the agency's current interim policy on compounding of bulk substances by outsourcers, which they argue ignores congressional intent under the Drug Quality and Security Act (DQSA) and violates drug law by allowing copies of FDA-approved drugs to be compounded in bulk while bypassing the FDA approval process

October 27, 2017 | Daily News

Endo Pharmaceuticals and subsidy Par Sterile Products are suing FDA to block the agency's current interim policy on compounding of bulk substances by outsourcers, which they argue ignores congressional intent under the Drug Quality and Security Act (DQSA) and violates drug law by allowing copies of FDA-approved drugs to be compounded in bulk while bypassing the FDA approval process

October 27, 2017 | Daily News

Another outsourcer compounding a REMS-protected opioid has been hit with an FDA Warning Letter due to issues with sterility. FDA posted this week a Warning Letter dated Oct. 10 to US Compounding, which currently compounds over 30 types of drugs, including morphine sulfate.

October 27, 2017 | Daily News

Just hours before President Donald Trump declared the opioid epidemic a public health emergency, MACPAC commissioners on Thursday (Oct. 26) examined approaches to combat and treat substance use disorders, such as incorporating substance use disorder care with physical care, expanding treatment options in rural areas, and eliminating the institutions of mental disease (IMD) exclusion, the latter of which was advocated by Trump later in the day.

October 27, 2017 | Daily News

President Donald Trump announced Thursday (Oct. 26) that he is instructing the U.S. Department of Justice to pursue lawsuits against pharmaceutical companies and individuals who illegally prescribe and traffic opioids.

October 26, 2017 | Daily News

President Donald Trump on Thursday (Oct. 26) declared the opioid epidemic a public health emergency, and outlined a number of steps being taken by the administration to address the crisis, including implementing best practices for opioid prescribing and advancing a public-private partnership to develop non-addictive painkillers.

October 26, 2017 | Daily News

President Donald Trump said Thursday (Oct. 26) as he declared the opioid epidemic a national emergency that his administration will soon approve more state Medicaid waivers that eliminate a Nixon-era statutory hurdle that prevents Medicaid funds from going to institutions of mental disease (IMD), and will announce a new policy to overturn the IMD rule.

October 26, 2017 | Daily News

Due to the failure of traditional clinical trials to predict the potential for opioid users to turn to illicit drugs, FDA under current law can and should more closely consider potential public health impacts in its decisions to approve and withdraw approval of drugs, especially in the opioid space, Patricia Zettler, former associate chief counsel for FDA and current associate professor of law at Georgia State University College of Law, argued during the Food and Drug Law Institute (FDLI) Symposium Friday (Oct. 20).

October 26, 2017 | Daily News

President Donald Trump will declare the opioid crisis a national emergency under the Public Health Service Act, but will not provide any additional funding, senior administration officials said on a background briefing call with reporters Thursday (Oct. 26), just hours before Trump was slated to make the declaration.

October 26, 2017 | Daily News

President Donald Trump will declare the opioid crisis a national emergency under the Public Health Service Act, but will not provide any additional funding, senior administration officials said on a background briefing call with reporters Thursday (Oct. 26), just hours before Trump made the declaration.

October 26, 2017 | Daily News

President Donald Trump will declare the opioid crisis a national emergency under the Public Health Service Act, but will not provide any additional funding, senior administration officials said on a background briefing call with reporters Thursday (Oct. 26), just hours before Trump made the declaration.

October 25, 2017 | Daily News

Sen. Debbie Stabenow (D-MI) and 19 other Democratic senators on Wednesday (Oct. 25) called on President Donald Trump to allow the government to negotiate lower prices for naloxone, an opioid overdose reversal drug, as the White House finalizes its emergency declaration on the opioid crisis.

October 25, 2017 | Daily News

FDA is pursuing research that could support a label indication for medication-assisted treatment (MAT), and provide direction for potential long-term use by patients suffering from addiction -- a move that could help promote more widespread use and coverage of MAT, FDA Commissioner Scott Gottlieb said at a Wednesday (Oct. 25) House Energy & Commerce hearing on the opioid crisis.

October 25, 2017 | Daily News

Rep. Elijah Cummings (D-MD) and Sen. Bernie Sanders (I-VT) introduced on Wednesday (Oct. 25) legislation to let the government negotiate drug prices in Medicare Part D, a policy that President Donald Trump backs but that the rest of his party opposes.

October 24, 2017 | Daily News

New Energy & Commerce member Rep. Jeff Duncan, who fills the slot vacated when Rep. Tim Murphy (R-PA) resigned amid a personal scandal, is an Obamacare critic and a proponent of Right to Try legislation.

October 24, 2017 | Daily News

An outsourcer compounding four REMS-protected opioids is issuing a voluntary recall due to potential microbial contamination.

October 23, 2017 | Daily News

House Oversight and Government Reform Committee ranking Democrat Elijah Cummings (MD) on Thursday (Oct. 19) began investigating reports that health plans and pharmacy benefit managers make it difficult for people to get less-addictive pain killers while making it easier for them to get cheaper, highly-addictive drugs.

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