FDA partners with WHO to expedite review of HIV drug applications
The Food and Drug Administration is working with the World Health Organization to pilot a process to share documents on HIV drug applications that have been approved or tentatively approved by the agency under the U.S. President’s Emergency Plan for AIDS Relief, or PEPFAR.
In this initial pilot, to be called the Collaborative Registration Procedure-Lite, or CRP-Lite, the FDA will, with the applicants’ permission, provide the WHO/PQP with minimally-redacted reviews of one or two HIV drug applications. The WHO/PQP will then use the FDA’s reviews to expedite its own regulatory decision making, producing review dossiers which can in turn be shared with regulators in resource limited countries to speed up their own regulatory review processes—making lifesaving drugs available to patients who need them the most.
“Since PEPFAR)was launched 15 years ago to battle the global HIV/AIDS epidemic, more than 17 million lives have been saved and currently over 14 million people living with HIV in the countries served by the program are being provided with safe, effective and low-cost antiretroviral therapy, including over 700,000 children,” FDA’s deputy commissioner for policy, planning, legislation and analysis Anna Abram said.
Abram continued,“As we mark this year’s World AIDS Day on December 1, we reflect on the progress we have made in the global fight against HIV/AIDS as well as the men, women and children living with HIV who do not have access to prevention, care and treatment. As part of our public health mission, the FDA has played an important role in supporting PEPFAR and the agency remains committed to doing what we can to facilitate timely access to these essential medicines.”
PEPFAR was launched in 2003 to address the global HIV/AIDS crisis by using U.S. funds to purchase, at low cost, antiretroviral therapies, including new combinations and formulations of medicines, for treatment in countries with limited resources that were hard-hit by the epidemic.
Mallinckrodt to spin specialty generics business off to shareholders
Specialty pharmaceutical company Mallinckrodt will be creating a new company focused on specialty generics and active pharmaceutical ingredients by spinning that business and its Amitiza (lubiprostone) off to its shareholders. The move, which is subject to board approval, would create two independent, publicly traded companies — one of which offers branded specialty products, the other offering niche specialty generics and API manufacturing.
“Today’s announcement is another important step forward in our journey to become an innovation-driven, pure-play, specialty pharmaceutical brands growth company,” said Mallinckrodt president and CEO Mark Trudeau — who will lead the “remaining” specialty brands business after the separation.
Mallinckrodt’s specialty generics business saw net sales of more than $850 million for the 12 months ended Sept. 28, which includes sales of Amitiza since Feb. 14. The new company would have roughly 1,600 employees and a leading acetaminophen business, with a portfolio that includes API and generic finished dose forms of controlled substances and other products, a specialty generics development pipeline, and a solid U.S. manufacturing footprint, Mallinckrodt said.
Mallinckrodt said it expects the move to be complete in the second half of 2019 or sooner. The spun-off company is expected to be listed on the New York Stock Exchange and assume the Mallinckrodt name and ticker symbol, MNK. Matthew Harbaugh, who currently serves as Mallinckrodt’s executive vice president, CFO and president of the specialty generics business, is expected to become president and CEO of the new company. Harbaugh will be stepping down as CFO to focus on the separation, the company said.
“Mallinckrodt has a more than 150-year legacy of operations in St. Louis and a proud history of supplying the highest-quality products to customers,” Harbaugh said. As an independent, U.S.-based company, I am confident that we will be well positioned to advance our R&D capabilities and continue to maintain our category leadership in controlled substances.”
The specialty brands company will be led by Trudeau under a new name that will be chosen at a later date. George Kegler has been named interim CFO. The remaining business will encompass a branded specialty pharmaceutical arm that saw more than $2.3 billion in net sales for the 12 months ended Sept. 28. It includes such hospital products as INOmax, Ofirmev and Therakos.
AllianceRx Walgreens Prime Survey uncovers medication management habits
A recent survey commissioned by home delivery and specialty pharmacy AllianceRx Walgreens Prime is uncovering how patients manage their prescriptions — and steps they can take to make the task easier.
Though the survey found that 57% of adults said they take prescription medicine regularly, it also found that 48% said they found it somewhat to very frustrating — nearly as many said they found doing taxes somewhat or very frustrating. Additionally, the survey found an interest in being proactive, with 52% of respondents noting they’re likely to start in October or November to avoid issues around new health insurance benefits that start Jan. 1. And 41% said they had already signed up for text or email notifications from their pharmacy.
“The survey results affirm steps we are already taking to make life easier for our patients,” said John Stephens, vice president of transformation and strategy at AllianceRx Walgreens Prime. “We recently improved our website to allow patients convenient, 24-hour access to order refills and track orders. We’re also increasing staff and expanding hours of operations to get our patients their medicine during the new year.”
In light of the survey results, AllianceRx recommended taking the following five steps to improve the experience of managing prescriptions easier:
- Use online tools — AllianceRx Walgreens Prime noted that its website allows patients to manage their prescriptions;
- Ask pharmacists about prior authorizations — If prior authorizations are required, the pharmacy might need new insurance information to update financial assistance and co-pay info;
- Ask health plans about medication coverage — Checking how medication coverage might change in a new plan year can help with planning copay costs;
- Ask doctors about appointments — Keeping in contact with physicians about prescription refills can make scheduling necessary appointments easier; and
- Ask doctors to verify the pharmacy they e-prescribe — Patients can verify with their doctor which pharmacy is listed on their record and make necessary updates.