Dr. Stephen M. Hahn Profile picture
Jul 15, 2018 17 tweets 9 min read Twitter logo Read on Twitter
The topic of this week’s #FDA #SUNDAYTWEETORIAL is #drugshortages. FDA does everything possible within our authority to help address shortages. While we’ve made progress to mitigate shortages; we must do even more to understand and address the root causes of persistent shortages
Manufacturing & quality issues are some of the proximate causes of drug shortages. Availability of raw materials; unexpected increases in demand, i.e. due to illness outbreaks or changes in clinical practice; or unavailability of other drugs in a class also can lead to a shortage
We’ve seen # of new drug shortages steadily decline due to work by FDA, industry and others. In 2017, we worked w/ manufacturers to prevent 145 shortages. There were still 35 new shortages last year, but this compared to peak of 251 new shortages in ‘11 bit.ly/2JiNGpf
Sterile injectables, which are critical for a wide range of medical treatments, are particularly at risk of shortage. Of the 35 new shortages in 2017, 26 were for sterile injectables drugs
Business decisions along the drug supply chain also can lead to shortages, e.g. decisions based on profitability, manufacturing costs, distribution quotas, patent life and company mergers. Many drugs in short supply have been low-profit generic medications bit.ly/2uwlnhJ
In 2012, in response the increase in drug shortages, Congress acted and gave #FDA new authority to help us prevent, mitigate and address shortages #FDASIA
But #FDA’s authority is limited, e.g. we can’t require a company to produce a drug or increase production, even if it’s medically necessary; we can’t control how much of a drug is distributed; and many business decisions can affect supply of a drug
Despite best efforts & impact of FDASIA, we continue to see ongoing shortages of medically necessary products. Even shortages of a small # of key drugs can place a serious burden on providers, threaten health care quality & create barriers to optimal care bit.ly/2mfrL9o
Enduring solutions require collaboration. That’s why we announced the formation of a Drug Shortages Task Force including leaders from FDA, @CMSGov & DeptVetAffairs. We will examine #FDA’s current shortage authorities & also evaluate reimbursement policies go.usa.gov/xUKU9
Task force also will explore incentives to encourage expansion of manufacturing capacity & enhanced quality. FDA is already taking steps to support new technologies that can improve manufacturing, & help reduce the chance that supply disruptions will occur bit.ly/2KVnHdd
Patients expect and deserve high-quality drugs. While preventing shortages is a top priority, we must ensure quality standards are not compromised. The #FDA works with manufacturers and other stakeholders to resolve problems in a way that ensures patient access to vital drugs
Task force will look at whether a list of critical/essential drugs would be beneficial, where uninterrupted supply is esp. important from a clinical perspective & where we may consider more sig. interventions to avert shortages, as well as financial incentives for manufacturers
We’ll look at whether it could help to expand #FDA’s authority to require applicants of certain drugs to conduct a risk assessment to identify vulnerabilities in their supply chain that could cause a shortage & establish risk mitigation plans to proactively address weaknesses
New solutions will require input from industry, patients, federal partners. We appreciate lawmakers’ strong commitment to this issue. #FDA intends to engage the public and hold a meeting in coming months to bring together stakeholders to discuss shortage issue; identify solutions
As hurricane season is upon us, I want to note that #FDA monitors storms and identifies FDA-regulated facilities that could be impacted. If and when storms hit, FDA staff stand ready to work with manufacturers to prevent and mitigate any potential storm-related drug shortages
We've seen how comms b/w FDA & manufacturers helps w/shortages. For empty IV bags direct comms with suppliers after #PR resulted in firms ramping up production to mitigate supply constraints. Thanks, for example, to @DouglasMedProd for expediting production/shipment of empty bags
We will continue to provide regular updates on our progress on shortage issues like these updates on FDA’s efforts to address specific shortages bit.ly/2yw0gkG and our efforts that target the root causes of drug shortages bit.ly/2J67htx

• • •

Missing some Tweet in this thread? You can try to force a refresh

Keep Current with Dr. Stephen M. Hahn

Dr. Stephen M. Hahn Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!


Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @SteveFDA

Sep 30, 2018
It’s the start of flu season – time to protect yourself and your family by getting vaccinated! In today’s #FDA #SUNDAYTWEETORIAL I’m going to talk about #FDA’s role in ensuring the safety, effectiveness, and availability of the 2019 influenza vaccines. #VaccinesWork #FightFlu
I know there are questions about the effectiveness and benefits of the flu vaccine given the severity of last year’s flu season, so I want to update you on what we’ve learned, the effectiveness of this year’s vaccine and why vaccination is important go.usa.gov/xPWhS.
We've made important modifications to this year's #Flu vaccine to improve its effectiveness; changing two of the strains (for the H3N2 and Influenza B components) to better reflect the influenza strains that we believe are most likely to circulate this winter. More on this later.
Read 22 tweets
Sep 9, 2018
Compounded drugs serve an important medical need for patients who can’t use an FDA-approved medication. In today’s #FDA #SUNDAYTWEETORIAL, I’m going to talk about what FDA is doing to preserve access to appropriately compounded drugs while protecting patients from serious risks.
In drug compounding, ingredients are combined, mixed or altered to create a sterile or non-sterile medication tailored to a patient - such as those with an allergy who need a drug without a certain dye or a child who can’t swallow a tablet and needs medicine in a liquid form.
But compounded drugs, which aren’t FDA-approved, may pose serious risks if not produced properly, potentially resulting in contamination or medications that do not possess the strength, quality or purity they are supposed to have bit.ly/2G7IpjB
Read 23 tweets
Sep 2, 2018
As kids are heading back to school, for this #FDA #SUNDAYTWEETORIAL I’m going to talk about MEASLES and the vital importance of vaccination. You may’ve seen recent news stories reporting cases of measles in parts of the US and EU. Most cases have occurred in unvaccinated people
In 2018 there have been 124 individual cases of measles in 22 states and D.C. Measles can spread when it reaches a community where there are groups of unvaccinated people. And travelers with measles continue to bring the disease into the United States go.usa.gov/xUzwa
Measles is caused by the rubeola virus and is highly contagious. It is normally passed through direct contact or through the air. The virus infects the respiratory tract, then spreads throughout the body, causing a skin rash, fever, cough and runny nose.
Read 19 tweets
Aug 19, 2018
Consumers want and expect safe, wholesome and affordable food. They deserve nothing less. In today’s #FDA #SUNDAYTWEETORIAL I’m talking about what steps the FDA, the states and produce farmers are taking - in collaboration - to ensure the safety of fresh fruits and vegetables.
We hear too often about food safety concerns involving fresh fruit and vegetables -most recently the outbreak of E. coli O157:H7 infections associated with romaine lettuce from the Yuma growing region, the largest such outbreak in the U.S. in more than 10 years.
From 1998-2008 there were 455 produce-associated food outbreaks, with more than 16,000 people becoming ill, more than twice the number of produce-associated illnesses from 1973-1997. This is a significant public health burden that should be largely preventable.
Read 25 tweets
Jul 30, 2018
THREAD ON NEW ENFORCEMENT ACTION: We’re taking action against manufacturers marketing “vaginal rejuvenation” devices to women by deceptively claiming the procedures treat conditions and symptoms related to menopause, urinary incontinence, & sexual function fda.gov/NewsEvents/New…
These products have serious risks and don’t have adequate evidence to support their use for these purposes. We’re deeply concerned women are being harmed by these procedures
In some cases, the devices are marketed to women who’ve completed treatment for breast cancer and experience symptoms caused by early menopause. Deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.
Read 7 tweets
Jul 29, 2018
For this weekend's #FDA #SUNDAYTWEETORIAL I’m going to talk about what FDA is doing to modernize clinical trials to reduce the cost of drug development, potentially lower drug costs and bring more safe, effective therapies to patients.
FDA’s mission is to both promote and protect public health. For medical products, this means ensuring that they are safe and effective for their intended use. Clinical trials are the primary vehicle for generating the evidence FDA needs to ensure that.
The traditional drug development paradigm calls for 3 clinical trial phases: A small phase 1 tests safety and dosing, phase 2 tests short-term side effects and effectiveness over a range of doses; and the large phase 3 assesses whether the product’s benefits outweigh its risks.
Read 22 tweets

Did Thread Reader help you today?

Support us! We are indie developers!

This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Don't want to be a Premium member but still want to support us?

Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal

Or Donate anonymously using crypto!


0xfe58350B80634f60Fa6Dc149a72b4DFbc17D341E copy


3ATGMxNzCUFzxpMCHL5sWSt4DVtS8UqXpi copy

Thank you for your support!

Follow Us on Twitter!