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NEW RELEASE TODAY!!
KV slashes price of Makena
KV Pharmaceutical has just announced it is reducing the price of the drug, sold as Makena, to $690 an injection. KV has also stated it is expanding its program to help women who still are having trouble affording the medication.
The company was taking the steps because of the "concerns" that have been raised, including the tight budgets state Medicaid programs were facing.
"While the new price may represent a significant reduction, it remains excessively inflated given that the original price was stratospheric compared to the compounded drug's price," said George Saade, president of the Society for Maternal-Fetal Medicine.
The March of Dimes, which has come under criticism for praising the drug's approval before the price was made public, announced it was severing its ties with the company, which had provided about $1 million in donations to the organization.
http://www.washingtonpost.com/national/pharmaceutical_company_slashes_price_
of_preterm_baby_drug_makena/2011/04/01/AFpP9hGC_story.html?wprss=rss_homepage
FDA, KV, and Over-the-top Pricing on Makena
KV Pharmaceutical, armed with exclusive rights to an FDA-approved drug for pregnant women, speculated that it had the market tied up. They slapped a big price tag on the drug and put it on the market for sale. At $1,500 a dose, the company thought it stood to take in significant sales. However, they didn't count on the expectant mothers-and their doctors and government representatives-to fight back (as they were used to getting their doses at $10 to $15 each). The FDA entered into the fray; however, the agency doesn't have the power to tell KV Pharmaceuticals to lower the price, but it can allow pharmacists to keep on compounding the drug as they have for many years. The FDA released their official statement on Wednesday morning (March 30) of this week.
http://www.fiercepharma.com/story/fda-thwarts-kvs-over-top-pricing-makena/2011-03-30?utm_medium=nl&utm_source=internal
KV Hydroxyprogesterone Caproate Loses Exclusivity
In a rare move for any regulatory agency, the FDA announced it would not enforce the monopoly status it had given KV Pharmacuetical's Makena amid its controversial plans to charge $1,500 per dose. The company's stock fell after the FDA's announcement that it would continue to use its enforcement discretion for other makers of the same drug that sell it for $10 or $15 a dose.
Resulting from this was a growing chorus of KV critics that lauded the FDA action as a fitting response to what they view as the drug marketer's greedy overreach. The pricing for Makena is "profiteering at its worst," said Dr. George Hubbell, the Missouri chair of the American College of Obstetricians and Gynecologists.
U.S. Senator Sherrod Brown, D-Ohio, who has castigated KV's pricing as "irresponsible," called the FDA decision "a victory for pregnant women, consumers, and taxpayers. This drug, which was developed with extensive taxpayer support, is too important to fall out of reach for pregnant women."
Doctors have for years widely prescribed the drug to help prevent pre-term births. KV merely paid another company to push an already existing and widely used drug over the bureaucratic hurdles to win approval. They had purchased the marketing rights for about $200 million. The FDA said it would not enforce KV's market protections unless others produced unsafe or substandard versions of the drug.
KV's investments can't justify the company's high price, according to a statement from Senator Brown's office, which concluded that -- at $1,500 a shot -- KV could recoup its $200 million investment 18 times in the first year, netting a $3.7 billion profit.
http://pharmalive.com/news/index.cfm?articleID=771522&categoryid=9&newsletter=1
KV Shares Slide After FDA Announcement
Shares of KV Pharmaceutical Co. fell 27 percent Wednesday after federal regulators said it "does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient."
"This announcement by the FDA will ensure that women with high-risk pregnancies continue to have access to a safe, effective, and affordable treatment option to prevent premature births," AHIP President and CEO Karen Ignagni said in a statement.
AHIP recently sent a letter to the FDA seeking clearer guidance on the availability of compounded drugs for high-risk pregnant women. The letter raised concerns "about the potential for patients' loss of access to the longstanding therapy as a result of the exclusivity granted to the newly approved drug and the extraordinary price increase established by the manufacturer" and requested that the FDA "provide clearer guidance on the availability of compounded drugs that may be needed to ensure affordable access for vulnerable populations." KV's Makena price hike has caused a backlash from lawmakers, consumers, and doctors.
http://www.bizjournals.com/stlouis/news/2011/03/30/kv-shares-slide-after-fda-announcement.html
J&J Splits Off Troubled Consumer-drug Unit
Johnson & Johnson is reorganizing its consumer business, including giving more attention to its McNeil Consumer Healthcare unit, which has been stung by around 20 recalls of popular over-the-counter products like Tylenol, Motrin, and Benadryl. The U.S. over-the-counter drug business, one of the new "organizations" will allow J&J to focus on McNeil, which sells products such as Tylenol, Motrin, Rolaids, and Benadryl. McNeil had been part of a larger group of consumer healthcare units. J&J said the changes will allow it to "give focused attention to quality and compliance, and the critical task of restoring McNeil Consumer Healthcare brands."
McNeil products have experienced repeated recalls since September 2009, taking tens of millions of bottles of products like Tylenol and Motrin off the shelves and costing $900 million in sales in 2010. The federal government recently took control of a plant in Port Washington, Pennsylvania, which was involved in many of the recalls. Also, another recall was announced this week when the company pulled about 34,000 bottles of Tylenol 8-Hour off the shelves because of a musty odor; the same odor responsible for five previous recalls. The source of the smell was found to be trace amounts of a chemical used to treat wooden shipping pallets. The company said it stopped using those wooden pallets in January.
http://abcnews.go.com/Business/wireStory?id=13259884&page=1
http://www.reuters.com/article/2011/03/31/johnsonandjohnson-idUSN3014140920110331
FDA Chemist and Son Charged with Insider Trading
An FDA chemist and his son were charged with using inside information about drug approvals to reap more than $3.6 million in profits, in an embarrassing blow to the health industry regulator.
The SEC has charged Cheng Yi Liang with illegally trading in advance of at least 27 public announcements about 19 publicly held companies. "Liang's conduct was calculated, repeated, and egregious. Liang was a serial insider trader who violated the public's trust for his own profit on numerous occasions," the SEC said in its complaint filed in federal court in Maryland.
The Justice Department has charged Liang and his 25-year-old son Andrew with conspiracy, securities fraud, and wire fraud for making $2.27 million in trades involving five pharmaceutical companies between November 2007 and March 2011.
http://www.reuters.com/article/2011/03/30/us-fda-insidertrading-idUSTRE72S6Q920110330
Gout Medicine Colcrys' Pricing Under Scrutiny
Recent drug-pricing news also includes an outrage among some in the media and in Congress related to colchicine (Colcrys). Like KV Pharmaceutical's Makena, whose retail price retail price jumped from $15 to $1,500 per dose, the colchicine, under the brand name Colcrys from URL Pharma, has skyrocketed from 10 cents to $5 per tablet.
The FDA's motives in ensuring regulatory standards were praiseworthy, said some, but the drug companies who came out ahead are taking unfair advantage of the situation. Some say that even though it is legal, it seems unjust for companies to take unscrupulous advantage of patients and doctors who rely on already well-established drugs.
A Giant Pain in the Wallet
Drug companies are making crucial, common drugs up to 100 times more expensive. Colchicine is all that keeps some 2 million American gout patients from suffering debilitating pain in their toes, elbows, wrists, and fingers. Doctors have prescribed colchicine for centuries. However, patients who take colchicine woke up with a new symptom recently: a giant pain in the wallet.
Until January of this year, colchicine was sold by many companies and cost as little as 10 cents per tablet. Now it's available only under the trade name Colcrys, sold by URL Pharma-for five dollars per tablet. This colchicine story along with a few others like it, have provoked ire among some patients and doctors about an otherwise praiseworthy effort by the FDA to get update older untested drugs.
http://www.slate.com/id/2289616
Drug Shortages May Result in Legislation
We faced an unprecedented shortage of 240 pharmaceuticals in 2010. A new report from the Premier healthcare alliance found that drug shortages have risen to "critical levels," endangering the public's health. The report that disruptions in the supply chain, including recalls, industry consolidation, and offshore production are largely to blame.
The report states, "In 2010, over 240 drugs were either in short supply or completely unavailable and more than 400 generic equivalents were backordered for greater than five days." It goes further and says that "In most instances, these did not progress to critical shortages, but point to instabilities in the supply chain that cause national concern. Many of the drugs identified in 2010 remain unavailable or in short supply in 2011."
The legislation would require pharmaceutical companies to inform the Food and Drug Administration in advance of any incident that could result in a drug shortage and would also require the FDA to give "up-to-date, public notification of any shortage situation."
FDA "Should Inspect All Foreign API Facilities"
The US FDA should carry out inspections of all overseas active pharmaceutical ingredient (API) manufacturers supplying the U.S. market to better protect public safety, according to two industry associations representing the fine chemicals industry. Inspections in high-risk regions like China and India are almost nonexistent when compared to the U.S. and Europe, posing a risk to public health.
Moreover, fees for the inspections should be levied on the sites being inspected to avoid placing too much of a financial and resource burden on the FDA, according to the European Fine Chemicals Group (EFCG) and the U.S.-based Society of Chemical Manufacturers & Affiliates (SOCMA). The two trade organizations have said that their members would be willing to pay the fees for these inspections when carried out on facilities they operate outside the U.S..
http://www.securingpharma.com/40/articles/891.php
Human Chorionic Gonadotropin May Relieve Intractable Pain
"Human chorionic gonadotropin (hCG), frequently used in fertility therapy, relieved intractable pain for most patients," according to a study presented at the American Academy of Pain Medicine meeting. In fact, "after a year of hCG therapy, seven out of eight patients were able to reduce opiate use by 30% to 50%," researchers found.
http://mailview.custombriefings.com/mailview.aspx?m=2011032801ashp
&r=3272950-bbbf&l=016-965&t=c
http://www.medpagetoday.com/MeetingCoverage/AAPM/25549
Irinotecan Hydrochloride Injection Recall Due to Fungal Contaminant
APP Pharmaceuticals, Inc. has issued a voluntary recall of five lots of Irinotecan Hydrochloride Injection due to the discovery of foreign material and nonsterility in one lot of Irinotecan injection. The injection is used for recurrent or progressive metastatic colorectal cancer. Three customers reported that they discovered a particulate in the product solution in Lot 870DE00301. Investigation of the returned vials confirmed that the particulate was a fungal microbial contaminant.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical
Products/ucm248598.htm
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