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Opioids

September 26, 2018 | Daily News

Bicameral negotiators left out of the final opioid legislation a pay-for that would have extended the time kidney-failure patients could stay on private insurance.

September 26, 2018 | Daily News

The final opioid legislation negotiated by House and Senate negotiators includes a number of FDA-focused provisions, including measures to expand the agency’s authorities in international mail facilities; allow the agency to impose certain packaging and disposal requirements for drugs that pose serious risks; and let FDA require labeling changes for drugs when new effectiveness information emerges.

September 26, 2018 | Daily News

The opioid legislation hammered out by House and Senate conferees includes a requirement that HHS, in consultation with FDA and other relevant agencies, develop materials describing the circumstances under which a pharmacist may decline to fill a prescription for a controlled substance.

September 21, 2018 | Daily News

The Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker is upset the Senate tucked into its recently passed opioid bill a provision expanding the sunshine law to require that drug and medical device makers also publicly disclose payments made to nurse practitioners, physician assistants and midwives – not just doctors and hospitals – for promotional talks, consulting and other interactions.

September 20, 2018 | Daily News

CMS on Thursday (Sept. 20) told assisters working to help people get coverage through healthcare.gov that certain victims of Hurricane Florence may qualify for an exceptional circumstance special enrollment (SEP) period that allows them additional time to enroll, and they may be eligible for other SEPs due to relocating outside of their region or other reasons.

September 20, 2018 | Daily News

HHS’ Biomedical Advanced Research and Development Authority (BARDA) has entered into a contract with Opiant Pharmaceuticals, a company that develops nasal sprays for substance use and eating disorders, to develop a fast-acting, long-lasting intranasal form of nalmefene to reverse overdose, HHS announced Thursday (Sept. 20).

September 18, 2018 | Daily News

FDA for the first time has applied its opioid safety protocols to immediate-release (IR) opioids intended for use in an outpatient setting and is requiring that training be made available to nurses and pharmacists -- not just prescribers -- who are involved managing patients with pain, the agency announced Tuesday (Sept. 18).

September 18, 2018 | Daily News

Despite being omitted from the Senate’s recently approved opioid bill, some rollback of a federal prohibition on using Medicaid funds to pay for substance-abuse treatment in large inpatient facilities may still be included in the final version of opioid legislation slated to be released in coming days, Senate aides say.

September 17, 2018 | Daily News

Following months of legislative debate involving myriad committees, the Senate on Monday (Sept. 17) passed an extensive package of opioid legislation by a vote of 99-1 but a new version privately hammered out by senators from both parties will be taken to conference with the House, a Senate aide told Inside Health Policy.

September 13, 2018 | Daily News

The Senate will vote on a package of opioid legislation Monday (Sept. 17), according to a spokesperson from Sen. Mitch McConnell’s (R-KY) office and the Senate Democrats’ online schedule.

September 10, 2018 | Daily News

Major health care and drug industry stakeholders are concerned the Drug Enforcement Administration's (DEA's) proposal to cut manufacturing quotas for certain opioids by 10 percent could exacerbate drug shortages and have a negative effect on patients with a legitimate need for opioids.

September 10, 2018 | Daily News

As stakeholders urge the Drug Enforcement Administration to rethink its proposed cuts to opioid production quotas, which they fear could cause increased drug shortages, one health policy expert argues the quotas are unlikely to have that much of an effect on the drug supply, especially as most of the highly publicized shortages are a result of manufacturing and facility issues.

September 10, 2018 | Daily News

In a study of more than 1,600 people injured in traffic accidents, researchers discovered that people with a certain variant of the stress-controlling gene FKBP5 were more likely to develop chronic pain than those with other variants -- a finding that could help pinpoint new non-addictive strategies for preventing or controlling chronic pain, National Institutes of Health Director Francis Collins wrote in an NIH Directors Blog post on Tuesday (Sept. 4).

August 29, 2018 | Daily News

FDA will scrap a 2014 guidance document on pain drug development and replace it with four, less-onerous guidance documents over the next six to 12 months in a bid to spur drug development, FDA Commissioner Scott Gottlieb says in a Wednesday (Aug. 29) statement.

August 29, 2018 | Daily News

Senate Republicans have cleared the Senate opioid package and are now awaiting for Democrats to clear it on their side, Senate Majority Leader Mitch McConnell (R-KY) said at a press conference Tuesday (Aug. 28).

August 28, 2018 | Daily News

FDA has sent warning letters to four online networks operating 21 websites for illegally marketing unapproved, misbranded opioids, including tramadol, the agency announced Tuesday (Aug. 28).

August 23, 2018 | Daily News

FDA has contracted the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a consensus study and issue a report on what evidence is needed to ensure clinical practice guidelines for opioid prescribing for acute pain are sufficient and how to generate said evidence, agency head Scott Gottlieb announced Wednesday (Aug. 22).

August 20, 2018 | Daily News

Sen. Edward Markey (D-MA) is calling for an overhaul of FDA's safety protocols for transmucosal immediate-release fentanyl (TIRF) products, pointing to data suggesting the agency has known that its current Risk Evaluation and Mitigation Strategies have allowed widespread off-label prescribing of the risky opioid product.

August 16, 2018 | Daily News

President Donald Trump called on Attorney General Jeff Sessions to bring a federal lawsuit against opioid makers and distributors rather than just joining state suits, and to explore ways to stop opioids from coming in from China and Mexico, according to a White House press pool report from Thursday (Aug. 16).

August 16, 2018 | Daily News

The Drug Enforcement Administration (DEA) is proposing to cut manufacturing quotas for oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine and fentanyl by an average of 10 percent for 2019 compared to the 2018 production quotas, the agency announced Thursday (Aug. 16).

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