Anthony Vecchione is Executive Editor of Drug Topics.

Anthony Vecchione

Demand for generics and biosimilars is growing. In 2017, generic drugs generated $265 billion in savings. New biosimilars could play a major role in increasing competition and driving down costs. 

 (OGD) and from the Therapeutic Biologics and Biosimilars team (TBB) about how the agency is helping accelerate generics to market, and the role pharmacists play in educating patients about the safety, effectiveness, and quality of generics and biosimilars.

Related article: Why Health Systems Are Making Their Own Generics

How is the FDA accelerating generics to market? What are some of the obstacles? What does the generic market look like going forward into 2019 in terms of approvals?

 FDA plays a critical role in increasing access to safe, effective, high-quality generic drugs to the American public. While FDA doesn’t have a direct role in when a product is marketed after approval or drug pricing, when more than one generic version of a drug is approved and marketed, it spurs competition and facilitates affordable options for consumers. Providing access to generic medicines is a top priority at FDA. 

The FDA Reauthorization Act of 2017 includes the Generic Drug User Fee Amendments Reauthorization of 2017 (

) and provides the generic drug program with increased resources to help promote more robust generic drug competition. The GDUFA II Commitment Letter represents the agreement reached by FDA and the generic pharmaceutical industry, along with discussions with public stakeholders. This was mandated by Congress. Under GDUFA we have taken steps to enhance access to generic products. We continue to review and enhance our Prioritization of the Review of Original Abbreviated New Drug Applications (

), Amendments, and Supplements Manual of Policy and Procedures to ensure we are working towards the utmost public health priorities. 

The GDUFA performance goals are intended to reduce the number of review cycles and increasing first-cycle approvals to potentially speed access to generic drugs. A highlight of the Commitment Letter is the new pre-ANDA program for complex generic drug products, which have been more challenging to develop and can lack generic competition. The goal of the pre-ANDA program is to clarify regulatory expectations for prospective applicants early in product development, assist with more complete submissions, and promote a more efficient and effective ANDA review process. 

One obstacle preventing generic competition is the gaming that delays generic drug approvals and extends brand monopolies beyond what Congress intended. Such gaming includes failing to provide certain branded products for comparative testing whereby generic drug developers experience problems accessing testing samples when branded products are subject to limited or restricted distribution. To help address this issue and provide transparency, FDA has posted a list identifying all drug products for which FDA has received an inquiry related to limited distribution of the marketed reference listed drug.

Related articles: FDA Assists Generic Drugmakers with New Guidances

These initiatives represent some of the activities under the Commissioner’s Drug Competition Action Plan that support the agency’s commitment to ensure that the American public has timely access to safe, effective, and affordable medicines.

While FDA has no regulatory authority over what products are marketed and when, the agency believes that the processes introduced though GDUFA II and the Drug Competition Action Plan will help to reduce approval times and increase the availability of generic drugs.

DT: As more generic drugs enter the market, what role can pharmacists play in educating healthcare providers about using generics? How are pharmacists positioned for this task? How does the FDA disseminate information/reports to the pharmacy community on generic drug development and review?

 FDA believes that pharmacists play an important role in educating patients about the medicines they are prescribed and on safety, effectiveness, and quality of generic medicines.

Related article: Why Generic Drug Prices Are Dropping

FDA routinely provides educational materials for pharmacists and healthcare providers at 

 on generic drugs via our website. The pharmacy community can also refer to the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) which identifies drug products approved on the basis of safety and effectiveness by FDA under the Federal Food, Drug, and Cosmetic Act and related patent and exclusivity information. The Orange Book is a resource that is widely-used by pharmacists and prescribers to identify generic drugs that are substitutable for various brand-name medicines. It is also available as a mobile app that can be downloaded from the App Store and Google Play.  

We also provide email updates on generic drugs including new guidances for industry, noteworthy approvals, and other important information on generic drug development and review to individuals who sign up to our RSS feed. Interested parties can go to https://www.fda.gov/aboutfda/contactfda/stayinformed/rssfeeds/default.htm, and receive email updates.

 What is the status of biosimilars in regard to lowering healthcare costs?

 While the FDA doesn’t regulate drug prices, we are charged by Congress to advance policies that maintain a balance between encouraging and rewarding medical innovation and facilitating robust and timely market competition. Robust competition expands patient access to more affordable products like generics and biosimilars. Millions of American patients may benefit from increased access to lower-cost, high quality biosimilar products.

As Commissioner Gottlieb recently stated during his speech at the Brookings Institution to announce the Biosimilar Action Plan (BAP), “enabling a path to competition for biologics from biosimilars is a key to reducing costs and to facilitating more innovation.” The FDA has approved 11 biosimilars to date. 

Gottlieb also outlined some of the obstacles biosimilars face in the marketplace, such as our current payment system, litigation, and rebating practices, but he also outlined four key FDA strategies in the BAP to accelerate biosimilar competition: 

Related article: FDA Promises Easier Generic Drug Applications

Improving the efficiency of the biosimilar and interchangeable product development and approval process.

Maximizing scientific and regulatory clarity for the biosimilar product development community.

Developing effective communications to improve understanding of biosimilars among patients, providers, and payers.

Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products.

The FDA will continue to advance new regulatory science tools that ensure patients benefit from rapid advances in science and technology that biological products can offer.

 What makes pharmacists well positioned for this task?

Pharmacists interact with both doctors and patients, making them an integral part of the exchange of information between both the prescriber and the patient. Pharmacists are also uniquely positioned for this task because of their specialized knowledge and experience about pharmacology and therapeutics, including the properties of drugs, pharmacokinetics, adverse drug reactions, and drug interactions. 

 What do you see as the biggest challenge for the healthcare industry as the new forms of drugs are introduced?

 Biological products have revolutionized treatments for many serious and life-threatening conditions, but it can be financially difficult for patients when the right treatment for their condition or disease is a high-cost biological product. With the cost of prescription drugs an ongoing concern in healthcare, the emergence of biosimilars offers more treatment options for patients, as well as much-awaited market competition that can potentially reduce costs for patients with serious medical conditions. 

Related article: Generic Cholesterol Meds a Boon for Patients

 What else might be important for our readers to consider regarding biosimilars?

 All FDA-approved biological products, including reference products and biosimilar products, undergo a thorough evaluation so that patients can be assured of the efficacy, safety, and quality of these products.  It is important for pharmacists to understand that FDA undertakes a comprehensive evaluation to ensure that biosimilar and interchangeable products meet the respective rigorous standard for approval. Healthcare providers and patients can expect that there will be no clinically meaningful differences between taking a reference product and a biosimilar when these products are used as intended. As with other drug products, healthcare providers should review the prescribing information in the labeling for detailed information about the approved uses.

Articles

Drug Topics recently spoke with the FDA about the role pharmacists can play in patient education.

What the FDA Wants Pharmacists to Know About Generic Drugs

Matt Robinson, RPh, pharmacist-in-charge at 

 in Owensboro, KY, was looking for a way to improve 

He found a solution in the Central Sync program, a component of VRxAssist from 

 that helped him to identify the right patients for the virtual program which maximizes adherence scores. Poole’s was a beta test site for VRxAssist.

“They enrolled the first 25 patients for us and coached us along the way. We were on-boarded into Central Sync on November 27, 2017 with one patient previously enrolled and Star Ratings of 3.36. We were off-boarded on January 24, 2018 with 66 patients. To date, we have 95 patients enrolled and Star Ratings of 4.52,” says Robinson.

Related article: Patients Like Pharmacies That Give Preventive Care

CMS developed the Star Ratings system to help consumers compare Medicare Advantage and Medicare Advantage Prescription Drug Plans based on factors of quality, cost, and coverage.

Pharmacies are rated on how adherent patients are, especially those taking medication for diabetes or hyperlipidemia, or those on ACE inhibitors, Robinson points out. “Using reports on 

, we enrolled outliers in med sync and got them compliant.” This helped to drive up his pharmacy’s Star Ratings.

Med Sync or medication synchronization, addresses the adherence problem by enabling pharmacies to fill patient prescriptions and sync all of them for a single, convenient pick-up day each month.

It allows pharmacies to optimize and streamline workflow while creating an opportunity for pharmacists to provide monthly check-ins and medication therapy management, focused on topics such as proper medication usage or mitigating side effects.

Robinson says that major pharmacy chains and thousands of independent pharmacists have implemented Med Sync, due to its ability to drive patient wellness, its compatibility with Medicare billing, and potential to enhance pharmacy business results.

“We were able to get the folks compliant with med sync and decrease the DIR fees we were paying.”

Robinson says that there’s been a decrease in phone calls and patients who had come in 10 to 12 times a month are only coming in once. He says that patients who are part of med sync need to call/come in less frequently because their prescriptions are synced up, generally for a monthly fill. Instead of coming in to get their meds each time one needs to be filled, they can come in once a month and get all of the prescriptions at once.

Robinson says that patients are no longer calling as much and the lack of phone calls opens up times for other things, like vaccinations, inventory management, marketing their compounding services.

“When they become adherent, we are sparing them from side effects down the road, particularly when it comes to diabetic patients and good kidney function. In Kentucky, there are high rates of obesity and diabetes is a huge part of that. Compliance is vital for these populations. It does benefit us, too, of course, but helping the patients become more compliant is the first priority.”

Related article: Top 5 Medication Adherence Tools

Al Babbington, CEO of PrescribeWellness says that community pharmacies can’t just rely on dispensing revenue. They need to take advantage of new and emerging payment models. But that leads to a quandary. They need additional staff to get the most out of new and emerging payment models, but they can’t justify the cost.

The company launched VRxAssist in July and describes it as a turnkey “virtual staff” solution, designed to provide pharmacies with support to expand services and capitalize on new revenue opportunities. 

Pharmacies license the software suite on a term basis, with a separate agreement to license the virtual staff for as long as they need. 

How new technologies are enabling pharmacies to increase adherence and their bottom line.

Virtual Staff in Community Pharmacies

In an effort to connect its mobile and online visitors to its health care services and to providers, Walgreens launched Find Care Now, a digital platform and marketplace.

The company is working with 17 participating providers with the goal of making it easier for customers to navigate and search for local and digital healthcare services.

Among the offerings: neighborhood health care clinics, urgent care, telehealth, lab testing, physician second opinions, and optical and hearing services, and even physician house calls in select markets.

 “This furthers our omnichannel efforts to meet the changing needs of our customers, and brings together our digital platforms with healthcare services that are easily accessible in Walgreens stores, and virtually,” Richard Ashworth, president of operations, told 

“It’s another example of how we’re working closely with healthcare partners to complement our pharmacy services, and makes it easier for patients to navigate care in their community,”  Ashworth says. 

Find Care Now is accessible through the Health Services section of the Walgreens mobile appand online at 

 Find Care Now includes the following healthcare providers:

DermatologistOnCall, national online dermatology service

Heal, on-demand doctor house calls in California, Washington, DC, and Northern Virginia

MedExpress Urgent Care, provider of neighborhood medical care

NewYork-Presbyterian Hospital, in collaboration with Weill Cornell Medicine and Columbia University Irving Medical Center, New York

Providence St. Joseph Health, including Providence Express Care in Portland, OR, and Swedish Express Care in Seattle

UHealth – The University of Miami Health System, Miami

Walgreens announces Digital Marketing Platform

Walgreens Unveils Digital Marketing Platform

NACDS has endorsed S. 2554, the Patient Right to Know Drug Prices Act, which helps pharmacies help patients reduce out-of-pocket prescription drug costs.

In a letter to Sen. Susan M. Collins (R-ME), lead author of the bill, NACDS 

, “NACDS believes gag clauses should not be allowed in contracts between health plans and pharmacies. Such clauses prevent pharmacists from informing patients when a medication can be purchased at a lower price without using insurance. The prohibition and/or removal of gag clauses in contracts between health plans, pharmacy benefit managers, and pharmacies will enhance patient access to medications, enable pharmacists to have improved relationships with patients, and keep healthcare costs for patients to a minimum.”

NACDS President and CEO, Steven C. Anderson, told 

 that the results of a national survey commissioned by NACDS, revealed that 83% of voters said that pharmacists provide credible advice for saving money on prescription drugs. Anderson says that the new legislation would remove a significant barrier that prevents pharmacists from providing even more critical information to patients. NACDS will continue to advocate for this vital bill and he urges its continued progress and its ultimate enactment, he added.

Companion legislation was introduced in the House of Representatives (H.R. 6143) by Rep. Lloyd Doggett (D-TX).

 to Secretary of Health and Human Services Alex Azar in response to a request-for-information related to the Trump Administration’s “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.”

NACDS supports the Patient Right to Know Drug Prices Act that ends gag clauses

Pharmacy Trade Group Applauds Senate Action Ending “Gag Clauses”

 designed to advance polices that will make the process for developing biosimilars more efficient.

At the Brookings Institution, FDA Commissioner Scott Gottlieb, MD, asserted that enabling a path to competition for biologics from biosimilars is key to reducing costs and to facilitating more innovation.

“By enabling a path for competition from biosimilars, we also give innovators an added incentive to invest in further research that’ll lead to the discovery of even better drugs that deliver additional benefits for patients.”

The commissioner noted that although less than 2% of Americans use biologics, they represent 40% of total spending on prescription drugs.

“Our plan is aimed at promoting competition and affordability across the market for biologics and biosimilar products”

Gottlieb says that preserving the balance between innovation and competition would entail modernizing regulatory requirements to maintain efficient, predictable and science-based pathways for drug review.

“Our aim is to reduce the time, uncertainty, and cost of drug development, while also supporting a competitive market through the efficient approval of lower-cost generic, biosimilar, and interchangeable alternatives after the expiration of patents or other statutory exclusivities.”

Gottlieb pointed out that biologics represented 70% of the growth in drug spending from 2010 to 2015, and they’re forecasted to be the fastest growing segment of drug spending over the next several years.

“To make sure that the next generation of breakthroughs remains affordable, it requires vibrant competition from biosimilars. But it also means that we must consider new payment approaches. Models that allow us to take advantage of the competition that biosimilars offer, says Gottlieb.”

He asserted that the current payment system, which reimburses drugs based on their average sales price, was designed in a single-source world. “It was a market of biologics where there was typically only one drug in a category. And there wasn’t a lot of therapeutic variety or competition.”

He contended that a new approach was needed for paying for these drugs. “An ideal system would reimburse biologics in a competitively bid scheme, where we could take full advantage of the multi-source competition.”

Gottlieb says that the biosimilars action plan applies many of the same lessons learned from the agency’s experience with generic drugs to accelerate biosimilar competition and includes four key strategies:

“I believe some of these actions can be transformative for sponsors’ ability to bring high quality biosimilars to market.”

As part of this effort, the FDA is seeking to strengthen its partnerships with regulatory authorities in Europe, Japan, and Canada. Such partnerships can enable greater efficiency in developing safe and effective biosimilars.

“And we’re also taking new steps to make the biosimilar development process more efficient.

“The FDA wants to make sure that biosimilar products have labeling that allows health care practitioners to make informed prescribing decisions for their patients. Our guidance gives recommendations to applicants on how to prepare this labeling for review by the FDA,” says Gottlieb.

FDA Unveils Biosimilars Action Plan 

Val Cardinale, who was the editor of Drug Topics for two decades and helped to guide the publication into its position as the leading news magazine for pharmacists, has died. He was 83.

In his 20-year career at the helm of Drug Topics, he established himself as one of the most respected editors in trade publishing.

He led the editorial direction of the magazine at a time when community and hospital pharmacy was undergoing drastic change.

The recipient of a Jesse H. Neal Award, Cardinale was known for his meticulous reporting skills and sharp prose. Editors and writers benefited from his passion for attaining the highest journalistic standards.

"Val’s legacy is still vital to the popularity of Drug Topics. He led in developing a content format that consistently delivers professional solutions in a practical and concise manner,” says William Mulderry, the publisher of Drug Topics.

Born on Manhattan's West Side, an area known as Hell's Kitchen, Valentine Cardinale enjoyed a long, successful career as a journalist after graduating from Iona College and Columbia University Graduate School of Journalism.

Before joining Drug Topics, Cardinale served as the editor of Adweek and Advertising News of New York (ANNY).

After his retirement in 2001, he started a successful career as a novelist, writing four books. His latest, “Breakaway,” was about his second favorite subject after journalism, hockey.

In his biography on his website he wrote: "I also love reading (newspapers, novels, biographies, box tops, you name it); hockey and baseball; traveling; gardening; and history, nature, news/commentary, and art, not necessarily in that order."

Cardinale was predeceased by his wife Mary, and is survived by his daughter Kathleen, son-in-law William, grandchildren Brian and Olivia, and sisters Mary and Josephine.

Author's note: I was fortunate to have worked for Val Cardinale for 13 years. He was a mentor who became a great friend. His wisdom and guidance will always be a source of inspiration to me.