Obama's Executive Order Spurs Drug Industry to Cooperate with FDA to Ease Drug Shortages

Obama's Executive Order Spurs Drug Industry to Cooperate with FDA to Ease Drug Shortages

This week marks the six-month anniversary of President Obama signing an Executive Order to help FDA in its efforts to prevent and resolve prescription drug shortages. Following the Executive Order, FDA sent out letters to drug manufacturers asking them to "voluntarily report to FDA if they saw the emerging potential for a drug shortage."

"I am both amazed and delighted to see the progress that’s been made," said FDA Commissioner Margaret Hamburg in a blog post (here). "Early notification to FDA of potential disruptions in drug supply has made a huge difference in our efforts -- and the numbers really tell the story [see chart below]."

"Since reaching out to industry, there has been a six-fold increase in early notifications from manufacturers," said Hamburg. "Also in that six month timeframe, we have been able to prevent 128 drug shortages, and we’re seeing fewer numbers of shortages occur – 42 new drugs in shortage reported in 2012, compared to 90 new shortages at this time last year. This data is a testament to how FDA exercises flexibility and discretion in much of our work on drug shortages and the importance of strong collaboration and constant communication with industry, health professionals, and patients."

According to the above chart, FDA projects that there will be only about 130 actual drug shortages reported in 2012 compared to 250 reported in 2011 and that FDA-industry cooperation will have prevented about 100 additional shortages. By FDA estimates, even if it didn't prevent any shortages, the number of drug shortages in 2012 would be about 230 compared to 250 in 2011. That is, FDA envisions the trend in drug shortages reversing with or without FDA intervention.

But with FDA and industry cooperation, there were only 42 new drugs in shortage reported in 2012, compared to 90 new shortages at this time last year.

The Fake Avastin Supply Chain: China, Syria, Denmark, Switzerland, UK, US, Doctors

The Fake Avastin Supply Chain: China, Syria, Denmark, Switzerland, UK, US, Doctors

Authorities investigating the importation of low-cost foreign pharmaceuticals into the U.S. have identified a supply chain that may have allowed fake cancer drugs to reach U.S. clinics, according to investigators and documents reviewed by The Wall Street Journal (see "Doctors, Drug Distributors Tied to Imports of Fake Avastin").

"In the case of the fake Avastin, its global route isn't yet clear, but what is known illustrates the circuitous path that pharmaceuticals can take before reaching consumers. Wherever the counterfeit Avastin was manufactured—possibly China—investigators are examining a zigzagging route that may have taken the product through Turkey and Egypt before it was sold to Swiss and Danish wholesalers and then to Mr. Haughton's U.K. wholesaler, River East Supplies Ltd., according to pharmaceutical-industry and law-enforcement officials. River East then shipped the product to U.S. doctors through a Tennessee distributor, according to Mr. Haughton."

It is illegal to import drugs that are approved by regulators in other countries, but not the FDA. It is also illegal for US citizens to knowingly or unknowingly purchase such drugs. This includes the doctors and clinics at the end of the chain who purchased the Avastin at below market prices ($1995 vs $2400 for a 400-milligram vial).

"Buying foreign-sourced drugs that don't meet FDA approval can carry criminal penalties for doctors who purchase them and then bill Medicare. Penalties can apply even to doctors who weren't aware the drugs were foreign."

It is even MORE illegal -- ie, immoral -- to purchase FAKE, counterfeit drugs such as the Avastin in question, which contained starch, salt, cleaning solvents and other chemicals and none of the drug's active ingredient, bevacizumab, according to Roche.

Here's my view of the Fake Avastin Supply Chain (sorry, but I couldn't fit all the complicit distributors in the image; eg, I left out Switzerland):

WHOOPS! I forgot the last element of the supply chain, the VICTIM, aka PATIENT!

FDA's Drug Shortages Team: Why Are They Smiling?

FDA's Drug Shortages Team: Why Are They Smiling?

"Hope on the Horizon," is the title of today's FDAVoice blog post by Margaret Hamburg, M.D., FDA Commissioner. The post (here) highlighted a presentation made by a patient at an FDA drug shortage briefing on Tuesday. The "FDA Drug Shortages" team -- pictured below -- "has been working day and night to address this problem," said Hamburg.

"While there is no simple solution to resolving drug shortages," said hamburg, "we are doing all that we can to make sure patients have access to the critical medicines they need when they need them. I’d like to give a special thanks to the FDA Drug Shortages team and all the other staff throughout our agency for their hard work and leadership on this topic."

Here's the "FDA Drug Shortages" team:

Why are they smiling? Also, what's with the uniforms? Is it to give FDA agents an "aura" of authority -- as opposed to REAL authority -- when they meet with pharma execs to address this problem?

Pharma Social Media Silent About Drug Shortage: Boehringer, Novartis, #FAIL!

Pharma Social Media Silent About Drug Shortage: Boehringer, Novartis, #FAIL!

The pharmaceutical industry is not interested in using social media to inform or support patients using their products. It's only interested in using social media to push out positive news about their companies and products. This is evident by the industry's deafening silence regarding the shortage of cancer drugs such as methotrexate, a drug used to treat children's leukemia among other maladies.

Letters from the American Society of Clinical Oncology, American Cancer Society of Pediatric Hematology/Oncology and Children's Oncology Group, a nationwide network of researchers, were sent to top executives at four U.S. makers of the drug pleading for help. Two of these companies -- Ben Venue Laboratories and Sandoz -- are owned by major non-U.S. Rx pharma companies (Boehringer Ingelhein and Novartis, respectively). The letters state in part:

"As you know, since December we have seen a significant decline in the country’s production of preservative-free Methotrexate (MTX). This drug is critical to the treatment of children with ALL. Approximately 3,500 children and teenagers are diagnosed with ALL each year, with cure rates approaching 90%. Without this drug, patients are at dramatically heightened risk of dying."

As reported in the Chicago Tribune (see here), "the FDA says the main reason for the shortages is manufacturing deficiencies leading to production shutdowns. Shortages also are resulting from companies halting production of drugs with low profit margins, companies consolidating in the generic drug industry and supplies of some ingredients shrinking."

"Established in 1938, Ben Venue Laboratories is the manufacturing arm of Bedford Laboratories, a Boehringer Ingelheim company," says the company's web site. "Bedford Laboratories is one of the largest generic injectable pharmaceutical companies in the United States, offering a broad range of multisource injectables across multiple therapeutic classes."

In November, 2011, Ben Venue Laboratories (Boehringer Ingelheim), for example, shut down its manufacturing and distribution operations at its site in Bedford, Ohio due to significant manufacturing and quality concerns (see here).

Meanwhile, the Twitter accounts of Boehringer and Novartis roll merrily along posting positive tweets about their commitment to cancer patients, while completely ignoring the cancer drug shortage issue. Here are some recent tweets:

• @BoehringerUS: "@WHO estimates that 84 million people will die of cancer between 2005 and 2015 without intervention. #WorldCancerDay"
• @Boehringer: "@martin_dudziak Very true. We are also committed and believe in continued research & clin trials as a major key factor in fighting cancer!"
• @MylanNews: "Mylan Committed to Expanding Access to High Quality, Affordable #HIV/AIDS Treatment. Company Honors #WorldAIDSDay"
• @Novartis: "Novartis continues to research ways to control tumor growth in advanced #breastcancer"

The Rx drug industry is betting its future on developing complex biologics to treat major diseases such as cancer. If the current crisis is any indication about how successful they will be in (1) manufacturing biologics and (2) using social media to inform the public about the products and support patients who depend on these products, then, IMHO, I  doubt they will be successful.

P.S. Meanwhile, Boehringer is developing a Facebook "game," Syrum, which is designed to "educate" the public on how the drug industry develops drugs (see "Pharma & Fun, Not Oxymoronic? Here Comes Gamification!"). I suggest the company's PR people can better spend time and resources using Facebook to support their patients. Currently, BI's Facebook page does not mention the drug shortage problem nor anything else that can be considered helpful to patients who take their drugs!

Should the US Government Step in to Ease the Current Drug Shortage Crisis?

Should the US Government Step in to Ease the Current Drug Shortage Crisis?

"The drug industry is floundering in its ability to provide the public with many of the basic medicines that are absolutely required for the treatment of a host of diseases," said Paul Torrence, former Section Chief, MIH, in a recent OpEd piece (see here).

Torrence called for a National Institute of People's Medicine that "would ensure that drug inventories are always well stocked. It would additionally be the driver and funder of cutting-edge drug discovery and development for antibiotics. Working through out-sourcing and contract mechanisms, the NIPM could rejuvenate research funds-deprived academics and mobilize small pharma to manufacture requisite medicines.

According to the FDA, "In 2010, there were 178 drug shortages reported to the U.S. Food and Drug Administration, 132 of which involved sterile injectable drugs. In 2011, FDA has continued to see an increasing number of shortages, especially those involving older sterile injectable drugs. These shortages have involved cancer drugs, anesthetics used for patients undergoing surgery, as well as drugs needed for emergency medicine, and electrolytes needed for patients on IV feeding" (see Drug Shortage FAQs).

Various causes of the current crisis have been suggested: (1) manufacturing quality issues, (2) market manipulation (eg, price gouging), (3) mergers of pharma companies who cut out low profit margin drug lines, and (4) lack of profits to be made from certain generic drugs.

Whatever the cause, the American Society of Health-System Pharmacists (ASHP) calls the current drug shortage in the US a "crisis" (view this video -- interview at 36 mins, 30 seconds).

The last time we heard of a crisis affecting the entire nation was the 2008 "financial" crisis. That was met with swift action by the US government, which intervened in the market to help ward off the crisis in lending (ie, shortage of money).

If the government can address a national money shortage crisis, why can't it also address a national drug shortage crisis?

Can the United States Ensure an Adequate Supply of Critical Medications?

That's the question ASHP asked in an FDLI Food & Drug Policy Forum article (attached to above cited post), the introduction to which states:

"This dramatic rise in the extent, duration and severity of shortages is occurring in an environment that is characterized by a near absence of communication between drug manufacturers and the Food and Drug Administration (FDA). This lack of transparency is a significant barrier to efforts to address drug shortages, and it represents a real and growing danger to patient safety. FDA has worked diligently to address this issue, but this work is hampered by the agency’s inability to require reporting of information that could be instrumental in minimizing the impact of a shortage or averting it all together."

More resources:

• Cancer drug shortages getting worse, FDA says (USA Today)


• Cancer Drug Shortage: Why Is This Not Front-Page News? (Health Beat Blog)

[This post originally appeared in Pharma Marketing Blog. 

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