header image

[Sign Up Now] to Receive Our FREE Daily SCVTV-SCVNews Digest by E-Mail

Inside
Weather


 
Calendar
Today in
S.C.V. History
March 29
1928 - Little dam victim, thought unidentified & buried in SCV, actually ID'd & buried in Chatsworth [story]
Newhall Cowboys


SILVER SPRING, Md. — Scott Gottlieb, the commissioner of the U.S. Food and Drug Administration, addressed the issue of drug shortages in the following statement released Thursday:

Without question, one of the most frustrating challenges that health care providers and patients must contend with is when a drug that’s medically necessary and critical to patient care is unavailable due to a shortage.

We know that the uncertainty over how long a drug will be in shortage, how to ration supplies in the meantime, or worse, how to prepare for a sudden event that might place unforeseen demands on a product that’s in short supply, adds burdens and stress on providers and patients.

The FDA also understands that hospitals and other healthcare facilities can feel blindsided by these shortages. They can seem abrupt and may be. Drug shortages also have significant costs to our overall health care system. The FDA is committed to taking new steps to address the root cause of more of these shortage situations.

While the causes of drug shortages vary, most shortages are due to disruptions in supply chain availability of actively marketed products. Among these interruptions, manufacturing and quality issues are the leading causes of drug shortages.

This includes outdated equipment in need of repair or replacement, unexpected issues with a product’s composition, and a manufacturer’s inability to maintain facility and product quality. The availability of raw materials can also be a key factor in creating supply disruptions.

A disruption from one supplier of raw materials can affect production for many drug makers who all depend on that one source of raw material. Companies that supply raw materials can also be subject to quality problems, leading to shortages.

Only two percent of shortages are a result of product discontinuation. For example, when companies that make competing products merge, and discontinue one of the competing products, this can cause a shortage. Manufacturers often make production decisions based on business considerations, such as a product’s profitability, manufacturing costs, distribution quotas and patent life.

We know that business decisions at any point along the drug supply chain can lead to shortages.

Historically, many drugs in short supply have been low-profit generic medications, for which the investment needed to ensure continued production can be less than that for higher profit products.

Even in the absence of any production issues and decisions, there are other issues that can precipitate a shortage.

For example, an unforeseen increase in clinical demand, changes in clinical practice guidelines, or even FDA approval of a new indication for an existing drug, can all lead to an unexpected surge in demand for a particular medicine. The increased demand can, in turn, lead to a shortage of that specific drug.

Given these challenges, the FDA is focused on doing all we can to mitigate existing shortages and prevent them from occurring. While we help avert and minimize shortages in many ways, the FDA can have the best impact by working more closely with sponsors to help prevent shortages before they occur.

This starts with the FDA knowing about potential supply disruption well in advance of an actual shortage.

The Food and Drug Administration Safety and Innovation Act of 2012 (known as FDASIA) generally requires manufacturers to notify us of any disruptions, such as manufacturing changes, production or shipping delays, and product discontinuations likely to affect their supply of prescription drugs for serious illnesses. This vital information allows the FDA to execute other actions within our authority to help avert impending shortages or lessen their impact.

These notification requirements are critical, but there are many times manufacturers abruptly discontinue, limit, or delay production under circumstances outside those for which they are specifically required to provide advance notice to the agency.

There are other times when companies notify the FDA of potential supply disruptions, but don’t provide enough details to allow us to make the fullest use of our resources to address the shortage. We need to know as much as possible about these shortages.

While this information sharing can sometimes be challenging, the more information manufacturers can supply the FDA, the more we can do to help mitigate the shortage. To address these challenges and opportunities, the FDA is exploring additional ways that we can encourage companies to voluntarily share more timely information about potential supply disruptions.

We may be able to take new steps to clarify the information the agency requires to inform us better about the extent of a shortage problem. We’re also looking at what additional steps we can take, under the existing law, to make the communications we receive more actionable.

This includes additional information that can help the FDA develop more effective options for managing a shortage.

Our ability to help resolve shortages also relies on industry seeking approval for drugs currently in short supply. When that opportunity arises, we do what we can to prioritize these circumstances. For example, if a new production facility or supplier is needed, we have the regulatory authority to expedite facility inspections and drug application assessments so that the facility can become operational as soon as possible.

We can also expedite review of a new or generic drug application that, if approved, may serve as an alternative therapy to a product facing a shortage. Even when a shortage situation is urgent, patient safety remains our top priority. We make sure that any approvals of such alternate therapies meet our standards.

Although we cannot mandate submission of applications for products in short supply, the FDA does alert other manufacturers of similar or alternative products to consider ramping up production to meet an anticipated increased demand for their product.
In cases where alternative manufacturing is not available in the U.S., or the manufacturers of U.S.-marketed products are not able to expand production, we may explore importation of a product from a foreign manufacturing source until the shortage is resolved. We carefully evaluate the overseas manufacturing site and product to protect U.S. patients.

We’re also taking steps to bring on new technology that can improve manufacturing, to help reduce the chance that supply disruptions will occur. The FDA has implemented an emerging technology program and established an emerging technology team to engage with companies about new production technologies that could, in the long run, prevent drug shortages caused by product quality and manufacturing problems.

One such technology is continuous manufacturing. As with any new technology, implementing CM presents challenges, such as the initial cost of investing in new equipment. The FDA is taking steps to reduce the cost and uncertainty of adopting CM as an important, long-term solution to improve manufacturing reliability. The goal is to prevent and mitigate future drug shortages.

Finally, as we learned from our experience in responding to the devastation in Puerto Rico following Hurricane Maria last year, predicting some forces that can lead to shortages is very hard. Given the complexities involved in drug manufacturing, especially for sterile injectable drugs, problems can arise at any point in the process.

When companies are proactive and have backup lines, and facilities and raw material suppliers are prepared for when things go wrong, we can more readily prevent future shortages.

Shortages are an inevitable consequence of an imperfect system. With better planning, we can minimize shortages throughout the supply chain. But, in the near term, we won’t be able to fully eliminate the possibility that new shortages will arise.

Meaningfully impacting the structures and market challenges that can give rise to shortages will require more coordination among public and private stakeholders.

We’re evaluating our current authorities to see what more we can do to better mitigate and prevent shortages, including receiving additional, key information from industry when they notify the agency about a possible shortage and identifying all establishments where manufacturing is performed associated with listed drugs and the type of operation performed at each such establishment.

It’s essential that we evaluate what additional steps we can take to reduce the incidence and impact of shortages.

It may also require us to work with Congress to re-evaluate our current authorities in these areas. One consideration might be to expand the FDA’s existing authority to require applicants of certain drugs to conduct a risk assessment to identify the vulnerabilities in their drug supply, including vulnerabilities that could cause a shortage, and establish risk mitigation plans to address those risks.

Anticipation, foresight and communication are keys to preventing and reducing the impact of shortages. When a manufacturer provides the FDA with advance notification before production is halted or put on hold, and a contingency plan is put in place, shortages can be more easily mitigated.

Without such efforts, shortages will certainly occur at a higher rate and their impacts will be greater than necessary.

To achieve our public health goals, the FDA needs to work collaboratively with industry. The agency cannot require a company to produce a drug, even if it is medically necessary. The agency cannot require a manufacturer to increase production of a drug, and we cannot control how much of the drug is distributed or which purchasers will be given priority.

And the FDA has no authority over business decisions that affect the supply of a drug made by manufacturers or other entities in the supply chain.

We must all work together to ensure that the supply chain infrastructure can withstand inevitable and unexpected disruptions. Mitigating drug shortages requires a sustained effort by industry, the FDA, and other partners to return to production levels that adequately meet the needs of patients.

We’re pursuing new ways to support industry efforts to identify critical facilities and products and develop such plans.

We’ll continue to do all we can to address these shortages. I’ll have more to share in the coming months.

Comment On This Story
COMMENT POLICY: We welcome comments from individuals and businesses. All comments are moderated. Comments are subject to rejection if they are vulgar, combative, or in poor taste.
REAL NAMES ONLY: All posters must use their real individual or business name. This applies equally to Twitter account holders who use a nickname.

0 Comments

You can be the first one to leave a comment.

Leave a Comment


Latest Additions to SCVNews.com
1928 - Little dam victim, thought unidentified & buried in SCV, actually ID'd & buried in Chatsworth [story]
Newhall Cowboys
Los Angeles County Public Works is updating the Los Angeles County Bicycle Master Plan.
April 16:  County Bicycle Master Plan Virtual Community Meeting
College of the Canyons mens golf got back on track during its return to conference play on Monday, carding a five-man score of 370 to top the eight-team field at Brookside Golf Course and maintain its unblemished conference mark.
Cougars Win Again, Keep Conference Streak
Los Angeles County Treasurer and Tax Collector, reminds property owners that the second installment of the 2023-24 Annual Secured Property Taxes becomes  delinquent if not received by 5 p.m. Pacific Time or United States Postal Service postmarked on or before Wednesday, April 10, 2024.
County Treasurer Reminds Property Owners of April 10 Due Date
Local nonprofit Fostering Youth Independence is seeking “Allies” to support Santa Clarita youth who are aging out of the L.A. County foster care system.
April 16: FYI Seeks Volunteers To Pair With Local Foster Youth
The Los Angeles County Department of Public Health today unveiled the latest L.A. County Health Survey, which gathers vital data on health behaviors, conditions, neighborhood settings, and the needs of L.A .County residents, informing future public health policies and programs.
Public Health Unveils the 2023 L.A. County Health Survey Findings
Due to the projected rain forecast, Eggstravaganza will now be held indoors at the Canyon Country Community Center beginning promptly at 10 a.m. on March 30.
March 30: Eggstravaganza Now Being Held Indoors at Canyon Country Community Center
To support the mental health of California's young people, the California Department of Public Health awarded $25 million to 28 tribal and community-based organizations across the state.
California Announces $25 Million in Awards for Youth Mental Health
The College of the Canyons Athletic Department will host a dedication ceremony to unveil the Michele Jenkins Softball Team Room in honor of the longtime board member and ardent softball program supporter’s nearly 40 years of service to the district.
April 16: COC to Host Michele Jenkins Team Room Dedication Ceremony
PFLAG Santa Clarita has announced the establishment of the Peggy and Jeff Stabile PFLAG SCV Scholarship. The scholarship will provide financial assistance to LGBTQIA+ students pursuing higher education and committed to advocating for LGBTQIA+ rights and promoting diversity and inclusion.
PFLAG SCV Announces Stabile PFLAG Scholarship
1934 - Bouquet Canyon Reservoir, replacement for ill-fated St. Francis Dam & reservoir, begins to fill with water [story]
Bouquet Reservoir
The California Department of Public Health launched the “Never a Bother” campaign, a youth suicide prevention public awareness and outreach campaign for youth, young adults, and their parents, caregivers, and allies.
California Launches New Youth Suicide Prevention Campaign
The Santa Clarita Master Chorale invites the community to "Let the Sunshine In," a delightful evening of food, wine and song at the annual Cabaret & Cabernet fundraising benefit.
April 20: Santa Clarita Master Chorale’s Cabaret, Cabernet Fundraiser
The Los Angeles County Department of Public Health cautions residents who are planning to visit the below Los Angeles County beaches to avoid swimming, surfing, and playing in ocean waters:
March 27 Ocean Water Warning
As an integral ingredient necessary to help the Santa Clarita Valley to flourish, feedback from the business community is the secret sauce for achieving great things.
SCVEDC Asks For the Business Community’s Opinion on Santa Clarita
Raise your heart rate while raising funds for the Santa Clarita Sister Cities Dollars-for-Desks campaign to provide school desks for students in Sariaya, Santa Clarita's Sister City in the Philippines.
April 13: Sister Cities Zumba-thon Fundraiser
Remo, Inc. is is the world's leading manufacturer and developer of synthetic drumheads and shells. They’ve been in business for 60 years
SCVEDC Company Spotlight: Drumming Up Big Business with Remo, Inc.
California State Assemblywoman Pilar Schiavo (D-Chatsworth) and Assemblyman James Ramos (D-Highland) have introduced AB 3074 the "School or athletic team names: California Racial Mascots Act."
Schiavo Introduces Bill to Prohibit ‘Derogatory’ School Mascot Names
Los Angeles County’s Justice, Care and Opportunities Department  in collaboration with Local Initiatives Support Corporation Los Angeles is proud to announce the 2nd Annual Pitch Competition for the cohorts of JCOD's Incubation Academy.
March 28: JCOD Incubation Academy Helps Grassroots Non-Profits For the Second Year
Children’s Bureau is seeking foster families and now offers two virtual ways for individuals and/or couples to learn how to help children in foster care while reunifying with birth families or how to provide legal permanency by adoption.
April 18: Children’s Bureau Hosts Virtual Orientation
The Sunburst track was constructed in 1887 by the Southern Pacific Railroad and was a part of the main line running between San Francisco and Los Angeles.
Enjoy Spring With a Ride On The Sunburst Track
California State Superintendent of Public Instruction Tony Thurmond hosted a Personal Finance Summit today where he announced his support for Assembly Bill 2927 (McCarty), legislation that would require a personal finance education course for California high school graduation.
State Superintendent Announces Support for Personal Finance Graduation Requirement
1847 - Probable birth date of Pico Canyon oil driller Charles Alexander Mentry [story]
C.A. Mentry
SCVNews.com