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March 21, 2019 | Daily News

A prominent consumer advocacy group and an FDA advisory committee chair are calling for FDA drug center chef Janet Woodcock to step down from her post in order to clear a path for the agency to revamp its regulation of opioids and implement recommendations made in 2017 by the National Academies of Sciences, Engineering, and Medicine.

March 21, 2019 | Daily News

A prominent consumer advocacy group and an FDA advisory committee chair filed a citizen petition on Thursday (March 21) demanding FDA slap an immediate moratorium on the approval of new opioids until it revamps its regulation and review of new opioids as recommended by the National Academies of Sciences, Engineering, and Medicine in 2017.

March 11, 2019 | Daily News

FDA experts applauded President Donald Trump’s fiscal 2020 budget request, which includes large increases for FDA, including a net $362 million boost for the agency’s taxpayer-paid budget authority, a $120 million increase for its user fee programs and $161 for new user fee programs.

March 07, 2019 | Daily News

The director of the White House Office of National Drug Control Policy (ONDCP) agreed to provide more information to the chair of the House Oversight & Reform Committee on the office’s drug policy strategy after a Government Accountability Office report released Thursday (March 7) found that the strategy lacked required information, such as measurements of performance goals.

March 06, 2019 | Daily News

Specialists in the fields of addiction and mental health urged Congress on Wednesday (March 6) to give more federal money to providers on the front lines of the opioid crisis -- including by funding several programs that were authorized in last year’s major opioid bill.

March 06, 2019 | Daily News

Provider groups and insurance plans applauded a CMS proposal to increase access to the opioid overdose reversal drug naloxone included in the agency’s 2020 draft Medicare Advantage and Part D call letter, but some groups called for CMS to reconsider a proposal on co-prescribing the drug with opioid prescriptions, saying that decision should be left between a provider and patient.

March 01, 2019 | Daily News

Bipartisan duo Reps. Markwayne Mullin (R-OK) and Earl Blumenauer (D-OR) plan to introduce legislation that would align the strict privacy scheme for substance abuse treatment records, 42 CFR Part 2, with the less stringent Health Insurance Portability and Accountability Act (HIPAA) sometime in March, spokespersons for their offices told Inside Health Policy Wednesday (Feb. 27).

February 27, 2019 | Daily News

House Energy & Commerce ranking Republican Greg Walden (OR) will speak with FDA Commissioner Scott Gottlieb about marijuana-related issues as part of a regular meeting the congressman has with the agency head, Walden told Inside Health Policy after speaking at an event at the American Enterprise Institute.

February 22, 2019 | Daily News

HHS Secretary Alex Azar highlighted the administration’s efforts to lower drug prices at the top of his State of the Department speech Friday (Feb. 22), though his half-hour presentation covered a broad range of initiatives and accomplishments.

February 21, 2019 | Daily News

West Virginia’s senators are asking lawmakers to support them in pushing HHS to align the strict privacy scheme for substance abuse treatment records with the looser Health Insurance Portability and Accountability Act (HIPAA), echoing the calls of physician and hospital groups.

February 21, 2019 | Daily News

Physician and hospital groups called for aligning the strict privacy scheme that requires explicit patient consent to share substance abuse treatment records with the more lax Health Insurance Portability and Accountability Act (HIPAA) standards, as well as for fewer regulations, in response to the HHS Office of Civil Rights’ (OCR) request for feedback on how HIPAA might be getting in the way of value-based care.

February 13, 2019 | Daily News

A coalition of organizations focused on health care, public health and safety, drug diversion prevention, and drug abuse prevention and treatment, and a former congresswoman, wrote to FDA Commissioner Scott Gottlieb urging the agency to embrace innovative, at-home systems for disposal of drugs when it implements wide-ranging legislation passed last year as part of congressional efforts to curb the opioid crisis.

February 07, 2019 | Daily News

The Senate health committee will hold a hearing next Tuesday (Feb. 12) to discuss progress in developing non-addictive pain therapies, how health care providers can better treat pain patients and potential federal barriers to improving care for people with pain.

February 06, 2019 | Daily News

FDA on Wednesday (Feb. 6) finalized guidance detailing the types of clinical studies and novel endpoints that can be used to support approval of depot buprenorphine products and how sponsors should design efficacy trials.

January 23, 2019 | Daily News

Health IT Now said at a briefing on Tuesday (Jan. 22) that it will focus on modernizing the Health Insurance Portability and Accountability Act (HIPAA) in 2019 -- though the group will not say what that entails -- and aligning the stricter 42 CFR Part 2 privacy with a revamped version of HIPAA.

January 18, 2019 | Daily News

In an effort to encourage drug companies to develop over-the-counter (OTC) versions of overdose-reversal drug naloxone, FDA has developed a model drug facts label with pictograms that show how to use the drug, which can help consumers better understand how to use naloxone without the supervision of a health care professional, agency chief Scott Gottlieb announced on Thursday (Jan. 17).

January 17, 2019 | Daily News

Federal Medicare advisers grappled Thursday (Jan. 17) with how CMS could better track opioid use in hospitals and encourage non-opioid alternatives, and it must report to Congress on those issues by March due to a mandate in last year’s landmark opioid bill.

December 05, 2018 | Daily News

The Institute for Clinical Economic Review (ICER) on Monday (Dec. 3) issued a final report featuring recommendations for how to develop policy on and increase access to extended-release medications for addiction treatment.

November 30, 2018 | Daily News

After six months and over 250 applications, FDA finally announced the eight winners of an innovation challenge in which medical device developers submitted to the agency their best ideas for preventing and treating opioid addiction.

November 21, 2018 | Daily News

As pharmacy and other health care stakeholders convened last week to discuss myriad issues surrounding illegal online sales of prescription drugs, one FDA official called for companies that manage and sell internet domain names to ramp up enforcement of their terms of use agreements and stop allowing violative website operators to continue leasing domains under different website names. This, the official said, would help fix the whack-a-mole issue on FDA’s side of enforcement.