Fred Y. Ganjian
By ELISABETH ROSENTHAL OCT. 7, 2014
The prices of some generic drugs have soared more than 1,000 percent in the last year, and federal officials are demanding that generic drug makers explain the reasons for the increases or potentially face new regulation.
The increased use of generic drugs has been one of the rare success stories in national efforts to curb the nation’s $2.8 trillion medical bill, since generics have historically been far cheaper than name-brand versions. More than eight in 10 prescriptions are filled with generic drugs, according to the Food and Drug Administration. In the 10-year period from the beginning of 2003 through 2012, generic drug use has generated more than $1.2 trillion in savings, according to the Generic Pharmaceutical Association.
But prices of some generic drugs have risen sharply recently, prompting the new congressional investigation, led by Representative Elijah E. Cummings, the ranking member of the House Committee on Oversight and Government Reform, and Senator Bernard Sanders, chairman of the Senate Subcommittee on Primary Health and Aging.
They said they undertook the investigation because of recent complaints from constituents, pharmacists and in the media. They are focusing on 10 drugs whose large price increases came to their attention.
“Generic drugs were meant to help make medications affordable for the millions of Americans who rely on prescriptions to manage their health needs,” Senator Sanders said in a statement. “We’ve got to get to the bottom of these enormous price increases.”
Some of the rises have been huge, according to data released by the lawmakers. The price that hospitals and pharmacies pay for a bottle of 500 tablets of doxycycline, a decades-old antibiotic, rose to $1,849 in April, from $20 in October 2013. The price they pay for a bottle of pravastatin, a drug to lower cholesterol, rose to $196 from $27 in that same time. The price of a pill of digoxin, a centuries-old medicine that is irreplaceable for some cardiac patients, rose to $1.10 this summer from 11 cents in 2012.
Some or all of such price increases are passed on to patients.
Late last week, the lawmakers sent letters to 14 drug makers that make or distribute the 10 generic drugs, requesting explanations for price increases. They may hold hearings depending on the response, which is due by Oct. 23. Some manufacturers have already promised cooperation.
“The first thing we need to understand is why these drug companies are raising their prices so dramatically in such a short period of time, which is why we asked for information about the costs to produce these drugs compared to the prices they are now charging,” Representative Cummings said this week. “Once we receive that information, we will be in a better position to evaluate the root causes of these massive increases and, if necessary, consider reforms.”
In a statement, Ralph G. Neas, president and chief executive of the Generic Pharmaceutical Association, said that facts about generic drug prices had been “mischaracterized,” focusing on a handful of drugs with big price increases, among the thousands of “safe, affordable” generic medicines.
Generic drug prices are generally lower than brand-name drugs because manufacturers are competing to sell medicines that are essentially interchangeable. But studies have shown that for competition to bring price down significantly, four or five companies usually need to be making a drug.
Drug prices can rise for several reasons related to normal shifts in supply. Companies can leave the market, resulting in decreased supply and less competition. A factory producing the drug may be temporarily closed for violations. But there has been increasing concern that, in some cases, prices rise because of questionable business practices or market manipulation. In the last several years, the Federal Trade Commission and state attorneys general have taken aim at a practice called “pay for delay,” in which brand manufacturers pay generic drug makers to hold off entering the market.
This summer, after a New York Times article about increases in the price of generic digoxin, the Connecticut attorney general issued a subpoena to Lannett, a Philadelphia-based company that is a major distributor of the drug, to assess whether it was engaging in “fixing, maintaining or controlling prices of digoxin” in violation of antitrust law.
In September, the company said its internal review concluded that it had “acted in compliance with applicable laws and regulations with regard to the pricing.”
The attorney general’s office said the investigation was continuing.
Drug shortages continue to occur in the United States. The number of drugs in short supply or completely unavailable may have gone down, but the number is still high. Worse, the types of products in short supply are as important as drugs used to fight cancer or as ubiquitous as normal saline for IV injection.
In 2011, FDA received reports of 251 drug shortages, of which 183 were sterile injectable drug shortages arose, 84 of which were sterile injectible drugs – but this number does not reflect the number of drug shortages that originated earlier and were continuing. “The number of new shortages has gone down in the last few years, if not gone up a little,” said Allen Vaida, PharmD, executive vice president with the Institute for Safe Medication Practices in Horsham, Penn.
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AUG 10, 2014
Drug shortages continue to occur in the United States. The number of drugs in short supply or completely unavailable may have gone down, but that number is still high. Worse, the types of products in short supply are as important as drugs used to fight cancer or as ubiquitous as normal saline for IV injection.
In 2011, FDA received reports of 251 drug shortages, of which 183 were sterile injectable drugs. In 2012, 117 new drug shortages arose, 84 of which were sterile injectable drugs — but this number does not reflect the number of drug shortages that originated earlier and were continuing.
“The number of new shortages has gone down in the last few years, but the total number of drugs on shortage has remained the same, if not gone up a little,” said Allen Vaida, PharmD, executive vice president with the Institute for Safe Medication Practices in Horsham, Penn.
The shortages affect hospitals and health systems nationwide. A national survey of 358 directors of pharmacy conducted in 2013 found that 99% (211 out of 214) reported that they had experienced a shortage of an injectable oncology drug in the previous year. And 64% said that they had completely run out of at least one injectable oncology drug.1
“It is unbelievable that in the United States we have this level of drug shortage,” said Erin R. Fox, PharmD, director of the Drug Information Service at University of Utah Health Care in Salt Lake City. “A manufacturing failure on this scale in any other industry would get so much attention.”
– See more at: http://drugtopics.modernmedicine.com/drug-topics/news/drug-shortages-continue-hospitals-cope#sthash.TMpjQr37.dpuf
(NaturalNews) Despite the Affordable Care Act’s promise of controlling healthcare costs, the prices of many drugs are quietly skyrocketing – doubling, tripling and, in some cases, even quadrupling in price – but for some reason, no one seems to know why.
There has been some speculation as to why Big Pharma is jacking up prices, but in the “opaque world of health care pricing, figuring out what’s driving the increase has become difficult – if not impossible,” reports the National Journal.
Oddly, pharmacists say they have no idea what is going on. Confused by the phenomenon, the National Community Pharmacists Association has appealed to Congress to hold hearings to figure out what’s going on. Per the National Journal:
The problem, the group says, is that pharmacists are getting gouged. Pharmacists trying to get their hands on generic drugs such as Pravastatin, a drug for patients with high cholesterol, or the [antibiotic] Doxycycline faced price spikes upwards of 1,000 percent in 2013, according to a survey by the group.
Some 77 percent of pharmacists surveyed by the association said in the last six months of 2013 they experienced 26 or more instances of a large upswing in the acquisition price of a generic drug.
Obamacare to blame – in part
In addition, 84 percent said price fluctuations have inhibited them from providing care and remaining in business, as a number of community pharmacies have been unable to fill prescriptions that would result in losses. Some patients have even decided against buying some medications because they cost too much.
But why are there such dramatic increases so suddenly?
“A lot of times, prices go up because of the rising costs of raw materials along with increased demand, resulting in drug shortage,” Tiffany Ngo, a Fairfax, Va., community pharmacist and founder of Cuddly Pandas, a homeopathic distributor, told me in an email.
She blames Obamacare, in part.
“I personally think that Obamacare does not reign the [sic] costs, at least at this time, because some of my customers still have problems finding doctors in networks and their medications are not covered with their new plans,” she said.
Patricia R. Audet, PharmD, Chair and Professor at the Department of Pharmaceutical and Healthcare Business, Mayes College of Healthcare Business and Policy at the University of the Sciences in Philadelphia, says supply and demand is only part of the issue.
“Patients have seen a drop in copays for generics and an increase in copays for branded and specialty drugs,” she told Natural News.
Drugs being shipped at ‘record high prices’
Regulations are also partially to blame; she said new Food and Drug Administration rules have caused Big Pharma costs to rise.
But Obamacare may be having a large role in this as well. Audet said that another reason why costs may be rising for patients is because insurance companies are shifting more of drug costs to them. She said “insurance plans are increasing number of tiers and pushing more drugs to higher tier status with more significant patient copays.” And she says provisions were not included in the law to specifically control the cost of drugs.
John Fazio, Rph, owner of New London Pharmacy, located in New York City, echoed Audet in noting that there are no Obamacare provisions aimed at keeping drug costs under control. She also told me something truly shocking – that drug price increases of 50 times “are not uncommon.”
“Dramatic price increases have been part of the pharmaceutical industry for years,” he said in an email. And while he also blamed “supply and demand,” Fazio noted that Big Pharma is shipping brand-name drugs “to the market at record high prices.”
A federal report credits Florida’s crackdown on pill mills and doctor shoppers with reducing deaths from prescription-drug overdoses by nearly one quarter. The report from the Centers for Diseases Control and Prevention (CDC) documents a 23% reduction in prescription drug deaths in Florida from 2010 to 2012.
State lawmakers in California are considering a bill that would allow patient to opt out of health plan requirements that certain prescriptions to be filled by mail order. The bill (AB 2418) has already passed the state’s assembly and is being considered by the Senate Health Committee. Specifically, the bill would “prohibit a health care service plan contract or a health insurance policy issued, amended, or renewed on or after January 1, 2015, that provides prescription drug benefits from denying coverage for the refill of an otherwise covered drug when the refill is ordered for the purpose of placing all of the enrollee’s or insured’s medications on the same schedule for refill.”
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FDA has approved a new oxycodone painkiller that’s designed to be more difficult for drug abusers to exploit. Targiniq ER (Purdue Pharma) is an extended-release tablet that combines oxycodone, the active ingredient in OxyContin, with the drug naloxone. The latter is used to reverse the overdose effects of opioids. Targiniq ER was approved for daily, round-the-clock, long-term pain treatment that does not respond to other medications. It is also said to be more difficult, but not impossible, to abuse.
Public health crisis
“The FDA is committed to combating the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the [United States],” said Sharon Hertz, deputy director of the FDA Division of Anesthesia, Analgesia and Addiction Products.
According to FDA, if the Targiniq ER pills are crushed and then snorted or injected, the naloxone will block the euphoric effects of the oxycodone. However, FDA officials concede that abusers can simply swallow the tablets instead of crushing them.
Overdose deaths linked to painkillers such as OxyContin and Vicodin (16,500 in 2010) have quadrupled since 1990, according to the Centers for Disease Control and Prevention.
– See more at: http://drugtopics.modernmedicine.com/drug-topics/news/harder-abuse-oxycodone-painkiller-approved#sthash.8ivdBQ7D.dpuf
A federal report credits Florida’s crackdown on pill mills and doctor shoppers with reducing deaths from prescription-drug overdoses by nearly one quarter.
The report from the Centers for Disease Control and Prevention (CDC) documents a 23% reduction in prescription drug deaths in Florida from 2010 to 2012. The report suggests that other states should follow Florida’s lead.
In recent years, Florida has become known as the pill mill capital of the United States. According to the CDC, between 2003 and 2009, drug overdose deaths in Florida increased 61.0%, from 1,804 to 2,905. Many were attributed to the pain killer oxycodone.
In response to the pill mills and the overdose deaths, Florida passed various laws and concentrated law enforcement efforts to shutter bogus medical clinics.
The result? Drug overdose deaths between 2010 and 2012 decreased 16.7%, from 3,201 to 2,666. Additionally, deaths per 100,000 persons decreased 17.7%, from 17.0 to 14.0. Overall, death rates for prescription drugs decreased 23.2%, from 14.5 to 11.1 per 100,000 persons.