Inactive Ingredients-Active Ingredients-Rick Perry, Texas-Hamburger Meat-Social Media

Will Pharma Experience It's Own 'Pink Slime' Social Media Crisis?

No doubt you have heard about "pink slime," the beef additive made from leftover trimmings. According to an article in today's Wall Street Journal (here), "the additive, which has long been used as a cheap filler in hamburger meat without anyone knowing or caring, has become the latest example of a product to fall prey to a social-media feeding frenzy after celebrity chef Jamie Oliver detailed how it is made in a TV special. Facebook, Twitter and other social media sites took it from there. Supermarkets and school districts across the country have been shunning it after mounting public pressure."
To counteract that "public pressure," which Tyson Foods Chief Operating Officer Jim Lochner said is merely a "two-week event," USDA and governors from several "pink slime" producing states (eg, Rick Perry, Texas) are mounting a counterattack. Iowa Gov. Terry Branstad said "We're going to consume it. We'll do everything we can to set the record straight."
"This is so clearly a movement that's been driven by consumers," said Willy Ritch, a spokesman for U.S. Rep. Chellie Pingree (D., Maine), who is pushing for a ban of the filler in school lunches.
USDA chief Tom Vilsack pointed to the difficulty of getting ahead of opposition to a product -- even if it is deemed safe by the government -- in a world fueled by social media. He also highlighted a disconnect that continues to grow between people and where their food comes from.
It's possible that the drug industry will one day face it own "pink slime" crisis because there is also a "disconnect" between consumers and where their drugs come from and the ingredients they contain.
Recently, we have seen cases where active ingredients in medicines have been replaced by miscellaneous substances having no medical benefit and cases where manufacturing problems have led to contamination such as Johnson and Johnson's problems with children's medicines (see, for example, "Unsafe Drugs: Is It Counterfeiters or the Supply Chain That's the Problem?").
These problems may be glitches in an otherwise safe drug supply chain, but did you know that up to 80 percent of the active ingredients in drugs used in the United States are made overseas? Hopefully, those ingredients meet high standards. Yet up to 149 Americans died in 2007 and 2008 after taking heparin, a blood thinner, contaminated during the manufacturing process in China.
What's often not mentioned, however, are the "inactive" ingredients in the pills we take. Viagra, for example, contains the following inactive ingredients:

• microcrystalline cellulose
• anhydrous dibasic calcium phosphate
• croscarmellose sodium
• magnesium stearate
• hypromellose
• titanium dioxide
• lactose
• triacetin
• FD & C Blue #2 aluminum lake

Patients are warned to discontinue taking medicines if they are allergic to any of the ingredients.
These ingredients are the "pink slime" of the drug industry. But whereas "pink slime" only constitutes a small percentage of ground beef, these "inactive" ingredients comprise the bulk of the pill's weight and volume.  AND they are probably made overseas with very little FDA supervision.
One of these ingredients may be as controversial to patients as "pink slime" is to hamburger eaters. In fact, this was the case with Johnson and Johnson's baby shampoo that consumers learned contained cancer-causing chemicals. That issue was big on social media for a while until J&J promised to phase out the product in the U.S. (it has been completely pulled from the shelves in other countries).
The food industry is blaming "misinformation" amplified via social media as the main cause of the consumer backlash against "pink slime." They have launched a two-pronged campaign to deal with the crisis: (1) issue "corrective" information, and (2) warn of higher prices if "pink slime" is no longer used in hamburger meat.
This sounds similar read more..

Federal Authorities-Prescription Drugs-Internet Pharmacy-Canadian Internet-Counterfeit Drugs

Canadian Internet pharmacy leader faces federal charges

The founder of a Canadian Internet pharmacy accused of selling counterfeit drugs will be arraigned this week in federal court, putting other operators around the world on notice that the U.S. is stepping up enforcement on that loose link in the supply chain in which thousands of Internet sites sell drugs of unknown origin to people without prescriptions.The 38-year-old Andrew Strempler, who was arrested last week, was a pioneer in this arena. In an indictment he and his former company RxNorth.com are accused of selling and shipping to U.S. consumers fake and misbranded drugs between early 2005 and the summer of 2006, The Wall Street Journal reports. Strempler sold his company to a competitor in 2006, and was believed to have hightailed it to the Caribbean after U.S. authorities accused him of selling counterfeit medications. Authorities globally have been trying to figure out how to attack the growing problem of counterfeit drugs making their way to consumers through this unregulated end-run around the legitimate supply chain.The arrest follows an FDA warning in May that fake versions of the ADHD drug Adderall, made by Teva Pharmaceutical Industries ($TEVA) and other generics companies, is showing up on Internet pharmacy sites. At least some of the counterfeit Avastin discovered in the U.S. in February squeezed its way in through a Canadian pharmacy company that delivers discounted prescription drugs from overseas to U.S. citizens.The owner of one Canadian Internet pharmacy acknowledged shipping at least some of the fake injectables of the Roche ($RHHBY) drug into the U.S. but said he notified authorities when he learned they were counterfeit.In a report in March 2011, the Counterfeit Pharmaceutical Inter-Agency Working Group, made up of a host of federal agencies and authorities, acknowledged the growing threat and said it was looking for ways to be proactive to a threat that is global in nature and difficult to monitor.  In a recent interview, Connie Jung with the FDA explained that illegal Internet pharmacies presented a particular challenge to federal authorities because they may sell counterfeit or other unapproved drugs. Jung is the acting associate director for policy and communications within the Office of Drug Security, Integrity and Recalls. It was established last year to focus on such problems as drug counterfeiting in an industry that now relies on a global supply chain. Part of its work is to coordinate with other agencies like Customs and the FBI to find ways to be proactive in the face of a serious threat."Consumers and healthcare providers can be confident that consumers are receiving safe, effective, high quality drugs from their local pharmacies," Jung says. "It is when we have entities that choose to buy outside the legitimate drug supply chain that harmful products may be introduced." The U.S. is not alone in trying to figure out how to get on top of this new outlet for counterfeits. China Daily reports that after a 5-month investigation into counterfeiting there, the State Food and Drug Administration sent 670 cases to the police for investigation. "Many counterfeit drug cases featured online advertisements and sales, underground production workshops and transfers through postal express," Yin Li of the SFDA says.- read The Wall Street Journal story
- get the China Daily storyRelated Articles:
Fake of Roche's Avastin shipped from Canadian supplier
Adderall shortage spurs counterfeiters to step in, FDA says
FDA warns 56 more docs of fake Avastin supplies
FDA commish suggests putting more bite in laws for counterfeiting
Fake Adderall surfaces as Congress turns attention to track and trace read more..

source:http://www.fiercepharmamanufacturing.com/

Pharmaceutical Industry-Supply Chain Security-Purdue Pharma-Cargo Theft

Here are some tips on cargo theft that might save you $75M

As I was reading the FDA's new SOP on cargo theft this week, I was reminded  of a conversation with Charles Forsaith, director of supply chain security for Purdue Pharma Technologies. He also coordinates the Pharmaceutical Cargo Security Coalition, which is dedicated to combating theft of pharmaceuticals in transit.Our talk centered on how U.S. manufacturers in the last couple of years have made a giant leap forward in protecting against cargo theft. He pointed out that last year there were only 5 stolen shipments valued over $500,000 and only three over $1 million, compared to 15 and 11 in 2009. That calculates to 33% and 25% decreases in just two years. Forsaith explained those results have been hard-won.Just a few years ago, the industry was losing loads that had values rivaling the numbers normally associated with the salaries of professional athletes.There was the dramatic burglary of and Eli Lilly warehouse where rope-rappelling thieves stole cancer, cardiovascular and depression medications. Loss: $75 million.There was a similar burglary at a GlaxoSmithKline warehouse. Loss: $6 million.And there was a 2009 heist of a rig from North Carolina, containing Novo Nordisk ($NVO) drugs, some of which later were tied to adverse reactions from patients who got them from a pharmacy chain. Loss: $10.9 million. It hasn't been that many years, Forsaith said, since drivers would arrive at a shipping dock and the only thing anyone was concerned about was whether they made it to where they were going by a particular point in time. "You didn't necessarily collect the name of the driver, get his cell number, make or a description of the truck, put a high-security cargo seal on the back door, tell the driver that he was not supposed to stop for so many miles. There were so many things that we took for granted."But with losses, and attendant publicity, growing changes were made. The coalition was formed, information was shared and companies were educated. The pharma industry learned from the practices, and the mistakes, of others such as manufacturers of high-end electronics and jewelry.Now companies vet their shippers to make sure they use two drivers and never leave a rig unoccupied. They paint trailers with large letters to make them easy for law enforcement to spot if they are taken. They use technology, like planting GPS devices in a load, or even use trailers with doors that close with a magnetic lock initiated by a cell phone and not even accessible by drivers. They constantly share information so danger spots for truck heists are quickly identified and can be avoided. This has all made loads harder to steal and easier to recover if they are taken.At the warehouse level, guards, lights and fencing can all make a difference, but Forsaith says he also urges warehouse operators to get to know their business neighbors and share contact numbers in case someone sees something unusual on a weekend, holiday or after hours. "It is just like a neighborhood watch, but just on a much grander scale."The world remains a dangerous place, Forsaith acknowledges. In other countries gangs often use weapons and violence to steal pharmaceuticals. But at least in the U.S., the situation is so much better.In fact, FreightWatch International reported last year was the first time on record in which the "pharmaceutical industry did not have the highest value per theft incident." That honor went to the electronics industry. -- Eric Palmer (Email | Twitter) read more..

source:http://www.fiercepharmamanufacturing.com/

Hormone Replacement Therapies-Estrogen Treatments-Brandon, Manitoba-Hormone Therapy

Pfizer making deep cuts at estrogen extraction plant

Pfizer ($PFE), which faces thousands of lawsuits over hormone replacement therapies, will cut about 40% of the workforce at a Canadian plant where one of them is made.The company says that by the end of next year it will eliminate 50 of 130 jobs at a plant in Brandon, Manitoba, where it processes conjugated estrogen from pregnant mares' urine (PMU), reports the Alberta Farmer Express. It uses the product to manufacture Premarin, a hormone replacement treatment originally developed by Wyeth, which Pfizer acquired in 2009.Pfizer told the publication that it must always be looking for "efficiencies and cost reductions by using our resources and technology more effectively." It says the restructuring will not affect its network of about 25 horse ranchers in Manitoba and Saskatchewan, from which it buys the raw PMU.According to Pfizer's website, Premarin is shipped globally and accounts for more than two-thirds of all estrogen prescriptions in the U.S. It says more Premarin is exported from Canada "than any other single pharmaceutical product." It doesn't mention the 10,000 lawsuits it has been fighting by women who claim that estrogen treatments were tied to their breast cancer.The company in December said it had settled about 5,000 of 10,000 lawsuits brought on behalf of women who had taken its hormone therapy drugs Premarin, Provera and Prempro. It said in a financial filing that it had set aside about $840 million to help settle claims. That disclosure came on the heels of a settlement it reached with three women who had been awarded more than $70 million from a jury who agreed that Pfizer's estrogen treatments contributed to their getting breast cancer.The Brandon plant was built in the 1960s and Pfizer inherited it as part of its 2009  acquisition of Wyeth. The Express says Wyeth reduced its network of PMU suppliers by half about 10 years ago after health studies identified the cancer risks associated with estrogen therapy and demand for the drugs fell off.- read the Alberta Farmer Express storyRelated Articles:
Pfizer settles hormone-drug suit after $72.6M jury award
For Pfizer, 5,000 lawsuits resolved, 5,000 to go read more..

source:http://www.fiercepharmamanufacturing.com/

Ethylene Glycol-Fda Inspectors-Hospira-Csl

CSL recalling product tainted with ethylene glycol

Two companies that have fallen under the shadow of FDA inspectors in the last year initiated product recalls this week. CSL Biotherapies ($CSL.AX) is recalling 6 batches of Albumex after tests showed some of it is contaminated with low levels of ethylene glycol. In a separate incident, Hospira ($HSP) is recalling syringes because some were believed overfilled.The Australian Therapeutic Goods Administration (TGA) in March quarantined 96 batches of the CSL product to investigate ethylene glycol contamination. The organic compound, which is commonly associated with antifreeze, has medical uses. It can cause poisoning in high enough doses.In an announcement Wednesday, the TGA says of those 96, 18 batches have low levels of ethylene glycol. Most of those have already been quarantined at hospitals or warehouses, but 5 that had already been exported are being recalled.Hospira began a recall of one lot of morphine sulphate injection after a customer reported discovering syringes containing more than 1 ml. Hospira distributed the lot, each box of which contains 10 prefilled cartridges, to "a limited number of hospitals" in 10 states, in-Pharma Technologist reports. The FDA alert says the affected lot was distributed in January but that Hospira has not received any reports of adverse events related to the problem.Both companies have had run-ins with the FDA over lapses in their manufacturing quality. Flu vaccine maker CSL was cited by the FDA in June for a lack of follow-through on raw material test failures to half-hearted investigations into adverse reactions suffered by hundreds of Australian children after they received the Fluvax shot last year. Twenty-three of those children landed in the hospital with seizures and fever. The Australian government ultimately withdrew the flu vaccine for use in children.The company has been working through manufacturing issues at plants in Austin, TX, and Rocky Mount, NC. The North Carolina facility was closed in December after quality issues were raised by the FDA but resumed production in January after the company threw extensive resources at fixing problems. It expects the plant to hit 60% to 70% production capacity by year's end.The company has been adding a slew of new people to its manufacturing and quality control ranks. Just this week it named industry veteran John B. Elliott senior vice president of operations. He will have responsibility for Hospira's global operations organization.- here's the in-Pharma Technologist story
- get the TGA announcement
- read the FDA alertRelated Articles:
Vax maker CSL hit with FDA warning
Hospira taps drug industry veteran to oversee operations
Hospira sees dim light at end of plant troubles read more..

source:http://www.fiercepharmamanufacturing.com/