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Compounded drug market needs transparency, more regulatory certainty, says Pew

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Even before the COVID-19 pandemic began to grip the country, many health system administrators found it difficult to procure specific drugs from outsourcing facilities, the FDA-registered compounders authorized to make office stock medications under federal law. 

While the pandemic has made drug shortages worse across the U.S., pre-existing supply chain issues were already both prevalent and deep-rooted.

Before the coronavirus fundamentally affected American life and the healthcare system, Pew Charitable Trusts conducted interviews with representatives from six outsourcing facilities to understand what might be causing these challenges. Four themes emerged.

For one, challenges specific to certain drugs can ramp up their manufacturing costs, which make them less attractive investments for compounders. A lack of transparency is also an issue, as it can lead to access challenges for office stock purchasers, even when adequate supplies are available from outsourcing facilities.

Meanwhile, regulatory uncertainty may deter companies from compounding certain products. And lastly, the sometimes short-term, unpredictable nature of FDA-declared drug shortages can disincentivize the compounding of office stock to help health systems manage these situations.

WHAT’S THE IMPACT

Providers can write prescriptions for compounded products that can be filled at pharmacies, but clinics and hospitals can also snag larger amounts of certain compounded medications, or “office stock,” directly from compounders to keep on-site and administer to patients as needed. Only businesses registered with FDA as outsourcing facilities may compound office stock; these facilities can also compound products that are listed on FDA’s Drug Shortages List.

Compounders can make liquid formulations of products for people unable to swallow pills; combine pharmaceuticals to simplify their use in trauma care; or dilute medications to strengths not offered by commercial manufacturers. These compounded drugs can pose some significant risks, as they haven’t been subject to the same kinds of quality standards and safety reviews as typical drugs. But they’re essential for some patients.

Based on the interviews, Pew pinpointed a number of interventions to address the supply problems. Some of these interventions are already underway, while some have been previously proposed.

The FDA, said Pew, could stand to revamp its drug shortages process in such a way that outsourcing facilities are more certain about the expected duration and severity of shortages. This would help compounders assess the business feasibility of producing drugs during such times.

To enhance transparency, outsourcing facilities and trade groups can provide additional outreach to providers about their products and capacity. Hospitals could also take part in group purchasing organizations that negotiate collective agreements between medical suppliers and multiple collaborating health systems, including smaller hospitals that may have a more difficult time than their resource-rich peers in securing office stock products.

Healthcare systems and providers can also standardize their orders of office stock formulations rather than ordering multiple forumations. This would incentivize outsourcing facilities to increase supply.

To support the development of a strong compounding market, the FDA can finalize its guidelines for the industry and continue its regular inspections of outsourcing facilities, according to Pew. And states, for their part, can ensure that their laws and regulations for compounds are clear and consistent with federal law — meaning the 11 states that allow compounders other than outsourcing facilities to make office stock products should change their laws to reflect FDA regulations.

THE LARGER TREND

Drug shortages have been a problem nationally for some time now, and the COVID-19 situation is only making matters worse. Some of the main issues are related to supply chain and the anticipated increase in ICU needs during the pandemic.

As of June 12, the American Society of Health-system Pharmacists said there were 214 drug shortages in the U.S., which affects all patients. One medication that exemplifies this is Erwinia asparaginase, a chemotherapeutic agent for both children and adults with cancer.

Among medical specialties severely affected are oncology, critical care and infectious disease.
 

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com



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source – Smithers Interior News

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The CFL has sent Canadian Heritage Minister Steven Guilbeault a revised financial request.

A CFL source said Friday the league is seeking roughly $42.5 million in aid. In April, it asked the federal government for up to $150 million in financial assistance in the event of a cancelled 2020 season due to the COVID-19 pandemic.

At the time, CFL commissioner Randy Ambrosie said the league was anxious “to be accountable to taxpayers,’ and would attempt to repay a portion of government assistance through ”community programs, tourism promotion, the Grey Cup, our digital channels.”

The source added the new request is to cover operating costs and player salaries for a shortened 2020 season. The proposal also includes a letter of support from the CFL Players’ Association.

The source spoke on the condition of anonymity because neither the government nor CFL have confirmed the request.

Last month, the CFL and CFLPA began talks to amend the current collective bargaining agreement to allow for an abbreviated season. The two sides must sign off on any changes for any games to be played.

But prior to the start of negotiations, the CFL presented the union with a memo outlining the conditions it wanted and a completion deadline of July 23.

When asked about the revised financial request, the CFL said, “We continue discussions with the federal government including discussions on our possible return to play.”

While the revision is for substantially less money, the CFL’s situation hasn’t changed much. It still requires financial assistance with revenues having dropped drastically due to the COVID-19 pandemic and expenses expected to continue to rise if it tries to play a season with no fans

The CFL’s initial request of Ottawa consisted of three tiers: It called for $30 million immediately to manage the impact the outbreak has had on league business; additional assistance for an abbreviated regular season; and up to another $120 million in the event of a lost 2020 campaign.

When Ambrosie spoke to a federal standing committee on finance in May, he was roundly criticized for failing to stipulate where the funds would go and not involving the CFLPA in the process. But the source said the revised proposal mirrors an authentic financial offer and contains more specific details than the original one did.

The earliest an abbreviated ‘20 season will begin is September, but Ambrosie has stated a cancelled campaign also remains possible.

If the CFL holds a shortened season, it’s expected to do so in a hub city. Winnipeg has been mentioned as a strong hub candidate, but the source said Regina also is under consideration.

Dan Ralph, The Canadian Press

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AM Best Affirms Credit Ratings of Fairfax Financial Holdings Limited and Its Core Subsidiaries

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OLDWICK, N.J.–()–AM Best has affirmed the Long-Term Issuer Credit Rating (Long-Term ICR) of “bbb” and the various Long-Term Issue Credit Ratings (Long-Term IR) on the unsecured debt and preferred equity of Fairfax Financial Holdings Limited (Fairfax) (Toronto, Canada). AM Best also has affirmed the Financial Strength Rating (FSR) of A (Excellent) and the Long-Term ICRs of “a+” of the subsidiaries of Odyssey Group Holdings, Inc. (Odyssey Group). Concurrently, AM Best has affirmed the FSR of A (Excellent) and the Long-Term ICRs of “a” of the members of the Crum & Forster Insurance Group (C&F), the members of the Zenith National Insurance Group (Zenith Group), the members of Northbridge Financial Corporation (Northbridge) (Toronto, Canada) and Wentworth Insurance Company Limited (Wentworth) (Barbados). In addition, AM Best has affirmed the Long-Term ICRs of “bbb” and the Long-Term IRs of Zenith National Insurance Corp. (headquartered in Woodland Hills, CA) and Fairfax (US) Inc. (Delaware), both of which are indirectly, wholly owned downstream holding companies of Fairfax. The outlook of all of these Credit Ratings (ratings) is stable. (See link below for a detailed listing of the companies and ratings.)

The ratings of Odyssey Group reflect its balance sheet strength, which AM Best categorizes as strongest, as well as its strong operating performance, neutral business profile and appropriate enterprise risk management (ERM). The ratings also reflect group member Odyssey Reinsurance Company’s (Odyssey Re) ranking among AM Best’s top global reinsurers, supported by the group’s diversified global geographic footprint, which includes reinsurance and specialty primary insurance, large-line capacity and broad product offerings. Somewhat offsetting these strengths is Odyssey Re’s challenging operating environment, with the uncertainty brought by the current COVID-19 pandemic developments.

The ratings of C&F reflect its balance sheet strength, which AM Best categorizes as very strong, as well as its adequate operating performance, neutral business profile and appropriate ERM. The ratings also reflect the benefits the group derives from its role within the larger Fairfax enterprise. C&F also benefits from its diversified and growing product portfolio and distribution networks. Management continues to focus on growth in its specialty business at appropriate rates, terms and conditions. Partially offsetting these positive rating factors are the competitive market conditions that persist in the commercial lines sector and relatively unfavorable expense levels.

The ratings of the Zenith Group reflect its balance sheet strength, which AM Best categorizes as very strong, as well as its adequate operating performance, neutral business profile and appropriate ERM. The ratings also are enhanced by the benefits the group derives from its position in the Fairfax enterprise. Furthermore, the ratings reflect management’s expertise and commitment to maintaining underwriting discipline throughout market cycles. Zenith’s underwriting performance over many years has outperformed the workers compensation market. Somewhat offsetting these positive rating factors is Zenith’s concentration of written premium in California and Florida, as well as the job market impact caused by the COVID-19 reducing payrolls.

The ratings of Northbridge reflect the group’s balance sheet strength, which AM Best categorizes as strongest, as well as its adequate operating performance, neutral business profile and appropriate ERM. The ratings of Northbridge also acknowledge the group’s position within Canada’s commercial insurance market, diversified commercial lines franchise and strong broker distribution network. The group continues to benefit from improved and strong underwriting performance within its small to mid-market commercial segment. Partially offsetting these positive rating factors are competitive market conditions that persist in Canada’s commercial and personal lines segments, and the group’s relatively unfavorable expense levels.

The ratings of Wentworth reflect its balance sheet strength, which AM Best categorizes as very strong, as well as its adequate operating performance, limited business profile and appropriate ERM. The ratings also are enhanced by the benefits it derives from its position in the Fairfax enterprise. In addition, the ratings of Wentworth are supported by its historically profitable underwriting performance and loss reserve position. The company benefits from its investment portfolio, which includes a significant allocation of cash and short-term securities. Partially offsetting these positive rating factors is the company’s concentration of property catastrophe exposure within its book of business, which subjects it to a substantial degree of volatility as evidenced over the past few years.

A complete listing of Fairfax Financial Holdings Limited and its subsidiaries’ FSRs, Long-Term ICRs and Long-Term IRs also is available.

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and AM Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and AM Best Rating Action Press Releases.

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in New York, London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2020 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

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Billionaire Musk’s net worth zooms past Warren Buffett’s

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(Reuters) – Elon Musk’s net worth soared past Warren Buffett on Friday as the chief executive officer of Tesla Inc <TSLA.O> became the seventh richest person in the world, according to the Bloomberg Billionaires Index.

Musk’s fortune rose by $6.07 billion on Friday, Bloomberg News said, following a 10.8% jump in the electric carmaker’s stock.

Buffett’s net worth dropped earlier this week when he donated $2.9 billion in Berkshire Hathaway <BRKa.N> stock to charity, the report added.

Tesla’s shares have surged 500% over the past year as the company increased sales of its Model 3 sedan.

The blistering rally also puts Musk in reach of a payday potentially worth $1.8 billion, his second jackpot from the electric car maker in about two months.

The stock is up about 38% since the close on July 1, a day before the company reported its quarterly delivery numbers.

Tesla’s solid delivery numbers heightened expectations of a profitable second quarter, which would mark the first time in its history that it would report four consecutive quarters of profit.

(Reporting by Shubham Kalia in Bengaluru; Editing by Raju Gopalakrishnan)

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