The U.S. Department of Health and Human Services (HHS) Sept. 20 explained the reasoning behind a memo, issued last week, that requires all rules coming out of the department and any of its agencies to be formally signed by the HHS secretary.

Since HHS Secretary Alex Azar has approved all agency regulations in the past, the only change the memo makes is requiring his signature. “Any speculation about this memo being motivated by policy considerations is utterly misinformed,” HHS said, adding that the intent is to minimize the risk of litigation.

“Agencies, including HHS, have had rules challenged in court on the grounds that they were signed by officials to whom rulemaking power was improperly delegated,” HHS said. Subsequently, the department conducted a review to ensure its rulemaking procedures were consistent with congressional intent, minimize litigation risk and provide public accountability. The memo is a result of that ongoing review.

In accordance with the memo, all rules issued by the department will continue to go through departmental and White House clearance, as they have in the past. They will then be signed by the secretary and the head of the agency involved.

HHS clarified that the memo only applies to agency rules; it will not apply to guidance or to the approval or clearance of drugs, vaccines and medical devices.

CDER lays out public speech rules for staff

The FDA’s Center for Drug Evaluation and Research (CDER) encourages its employees to speak at conferences and publish articles in professional journals or lay publications on topics related to their work or their areas of expertise – so long as they’re approved by supervisors.

A new CDER Manual of Policies and Procedures (MAPP) released Sept. 21 spells out how those articles and speeches are to be reviewed and cleared. It also draws the line between employees’ work-related speech and their personal speech.

Considered “sensitive” under the MAPP, any FDA-related articles and speeches prepared by CDER employees, whether for work or an outside activity, and intended for an external audience will require review and clearance by a designated official. In addition to speeches and articles, clearance would be required for materials such as monographs, slide presentations, books, films, exhibits and posters. Nonpublic information may not be used in outside work, according to CDER.

The MAPP clarified that FDA-related web postings by employees to social networking sites, including blogs, “may be considered official communications when done in an official capacity or when posted using government networks or a government-issued email address.” As such, they also require appropriate agency clearance. Clearance is not required if the social media post is not FDA-related and the author doesn’t disclose an FDA affiliation.

When FDA-related articles or speeches have significant policy implications, they must accurately represent official FDA policy to be cleared. If they are inconsistent with that policy, they must include a disclaimer stating that the article or speech has been reviewed by the agency and determined not to be consistent with its views or policies; thus, it reflects only the views and opinions of the author.

The review and clearance process should take no more than 30 days, according to the MAPP. Articles and speeches with co-authors from more than one CDER office must receive clearance from each office. The MAPP provides for parallel reviews that can be conducted simultaneously and coordinated by the lead author.

Health Canada opens quicker path for COVID-19 drugs

Canada’s interim order pathway, signed last week, is expected to expedite the availability of COVID-19 therapies and vaccines for Canadian patients.

The order introduces temporary regulations to speed the authorization for importing, selling and advertising COVID-19-related products without compromising patient safety. The new tools available under the order allow Health Canada to:

  • authorize drugs not yet licensed in Canada or elsewhere with a modified set of requirements;
  • accept applications for a COVID-19 product with fewer requirements, based on the authorization of a trusted foreign regulatory authority;
  • expand the use of an authorized drug to include a COVID-19 indication based on known evidence, with or without an application from the market authorization holder.

The interim order also introduces a “pre-positioning” mechanism to allow promising pandemic treatments to be placed in Canadian facilities before they’re authorized to allow for quicker distribution upon authorization. Pre-positioning is restricted to promising COVID-19 drugs and vaccines for which the Canadian government has entered into a procurement contract with the manufacturer.

The importer of products to be pre-positioned must have a Canadian establishment license, and the product cannot be used until it’s authorized by Health Canada.

EMA OKs COVID-19 use of dexamethasone

The EMA last week endorsed the use of dexamethasone to treat hospitalized patients with COVID-19 who require oxygen.

The endorsement applies to use of the drug to treat adults and adolescents at least 12 years of age and who weigh at least 40 kg (about 88 pounds). The recommended dose is 6 milligrams once a day for up to 10 days.

The EMA said its endorsement is based on the results of the RECOVERY study, which showed that, in patients on invasive mechanical ventilation, 29% of those treated with dexamethasone died within 28 days of starting dexamethasone treatment compared with 41% of patients receiving usual care. In patients receiving oxygen without mechanical ventilation, the figures were 23% with dexamethasone and 26% with usual care. There was no reduction in the risk of death in patients who were not receiving oxygen therapy or mechanical ventilation.

A corticosteroid, dexamethasone has been available for decades in the EU to treat a range of inflammatory conditions. Companies that market dexamethasone may submit an application to the EMA or national medicines agencies in the EU to request that the COVID-19 use be added to their product’s license.

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