Federal regulators may finally step in an take a real stance against the pharmaceutical industry’s rampant price-gouging.

Pharmaceutical companies have been notoriously price-gouging. The recent scandal centered around the ridiculously inflated cost of Daraprim showed how carelessly pricing is regulated.

Many have been left wondering if federal lawmakers will take action against the high price of life-preserving medications.

Putting Price-Gouging In the Spotlight

Pharmaceutical companies have created a pattern of acquiring the rights to certain drugs and then raising the cost.
Image: Buzzsaw Mag

Drug prices have been steadily increasing throughout the past decade. The first big hit was when Gilead Sciences priced the hepatitis C treatment Sovaldi at $84,000.

The high price of prescription medication received a renewed wave of attention when Turing Pharmaceuticals raised the price of Daraprim, an antiparasitic drug that protects seriously ill patients with weakened immune systems.  CEO Martin Shkreli made the decision to raise the toxoplasmosis treatment from $13.50 to $750 a pill.

Although he rescinded his original announcement, media broadcasters publicized widespread outrage from politicians, health professionals and patients.

Canadian drugmaker Valeant Pharmaceuticals International added fuel to the fire by raising the price of two heart medications, Nitropress and Isuprel, by 525% and 212% respectively. Many of these companies have started a pattern of acquiring the rights to sell a certain drug before raising the price a few hundred times.

On top of that, Citron Research accused Valeant of conspiring with specialty pharmacies Philidor Rx Services and R&O Pharmacy in a plan to generate phony sales.

The report sheds light on a stark jump in drug costs for both new breakthrough medications and older generics.

How To Combat The Increase

Patients protest Congress to fight Big Pharma’s standard of high pricing.
Image: US News

John Rother, CEO of the National Coalition on Health Care, has been working on a campaign to lower drug prices.

After the high price of Sovaldi and others brought attention to price-gouging, many politicians have begun to highlight the problem in their political campaigns.

“For lawmakers who are concerned about our fiscal standing, this is going to be an ever-more central issue,” Rother said.

According to a Health Affairs article, drug costs had increased 12.6% in 2014. While some are calling on regulators to step in, others believe that government interventions could have additional consequences.

“I’m very worried that on the pricing side, policymakers could be clumsy in trying to fix something and maybe make other problems,” Chip Kahn, Federation of American Hospitals CEO, said.

Both Democrats and Republicans have planned to address the issue in their platforms. Presidential candidates Hillary Rodham Clinton, Bernie Sanders and Marco Rubio are condemning the current system that allows drug companies to set their own prices.

Under Sanders and Clinton’s health care reform, Medicare would be given the ability to negotiate with drug companies to set prices. Patients would also be allowed to access to cheaper drugs from foreign providers.

Independent Health’s director of pharmacy services Sheila Arquette believes regulators will take action upon realizing that the current price of drugs makes health maintenance unsustainable.

Arquette recommends that drugmakers and insurers work together to find solutions, in addition to being more transparent about research and development costs.

“We have to be transparent, because I don’t think any of us really understand the whole picture,” Arquette said. “We need the manufacturers to come to the table and just be honest with us.”

The post Will Federal Regulators Take Action Against Pharmaceutical Price-Gouging? appeared first on Citizens Report.

The Trans-Pacific Partnership Agreement protects the exclusivity of biologic medicine in international markets, but Big Pharma isn’t satisfied with the details of the deal.

The Trans-Pacific Partnership Agreement, which deals with intellectual protection for certain drugs, is extremely controversial.

The agreement between the U.S. and 11 other countries will soon be up for debate in Congress. However, the current plan doesn’t satisfy pharmaceutical companies or consumers.

The Stipulations Of The Deal

The trade deal won’t change data exclusivity in the U.S., but would instead apply protections to drugs sold in partner countries like Australia, Brunei, Vietnam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru and Singapore.
Image: Activist Post

Under the agreement, countries must protect data for biologic medicines. Biologic medicines, produced by living cells, would be protected abroad for a minimum of five to eight years.

Big Pharma was hoping for at least 12 years of protection while consumer groups wanted to keep minimum exclusivity.

The rule would give certain companies a monopoly on drugs and prohibit others from creating biosimilars for a pre-decided period of time. Similar drugs cannot enter the market with clinical trial data from the original drug.

Currently, U.S. federal law gives biologics data exclusivity for 12 years. The trade deal won’t change that at home, but instead apply exclusivity to partner countries like Australia, Brunei, Vietnam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru and Singapore.

Many countries don’t implement data exclusivity. The agreement would require that these countries create laws that would give certain companies a monopoly for five years. 

“In the U.S., I don’t think there would be that much that would need to change,” said Joy Liu, a partner at Ropes and Gray who advises drug and biotech companies on FDA-related matters.

Domestic pharmaceutical companies who invested in the research and development of drugs abroad would be affected by competition in foreign markets, which is the reason why the industry has called for data protection. 

“PhRMA believes that strong intellectual property protection is necessary for the discovery and development of new treatments and therapies for the world’s patients,” said John Castellani, CEO of industry group the Pharmaceutical Research and Manufacturers of America, in a statement.

Castellani believes that biologic medicines are “next wave of innovation in our industry.”

“While we await final details, it appears that the Ministers missed the opportunity to encourage innovation that will lead to more important, life-saving medicines that would improve patients’ lives,” Castellani said.

Criticisms Far And Wide

Critics argue that the deal allows companies to extend monopolies overseas.
Image: Minneapolis Fed

Many critics believe that the deal is about concentrating power, not ensuring fair trade.

Peter Maybarduk, director of consumer advocacy group Public Citizen’s Access to Medicines Program, said the deal still allows companies to stop biosimilars from entering the market. 

“The problem of drug pricing is increasingly out of control in the U.S. and everywhere,” Maybarduk said. “Of course we need to pay for medical innovation, but there are more efficient ways to do that than monopolies.”

Doctors Without Borders also disagreed with the deal. 

“Although the text has improved over the initial demands, the [trade agreement] will still go down in history as the worst trade agreement for access to medicines in developing countries, which will be forced to change their laws to incorporate abusive intellectual property protections for pharmaceutical companies,” said Judit Rius Sanjuan, legal policy adviser to the group’s access campaign, in a statement.

Biologics are given patents that could make data exclusivity unnecessary. While patent laws prohibit biosimilars from joining the market for a certain time period, the pharmaceutical industry criticized them as weak in comparison to traditional drugs, said Arti Rai, a law professor at Duke University.

Waiting On Congress

Congress must approve or reject the deal without amending it.
Image: The Real Daily

Congress had previously agreed to fast track the agreement, but it’s not clear if Congress will agree to the deal now. The regulatory body must approve it or throw it out without amending it.

The Senate Finance Committee won’t approve the agreement unless the intellectual property right laws of U.S. trade partners are created and expanded.

The chair of the committee, Sen. Orrin Hatch (R-Utah), fully expects the Trans-Pacific Partnership agreement to include 12 years of regulatory data protection for biologics.

However, Democrats expressed concern in July that the deal may be rejected  if it doesn’t conform to the agreement reached by House democrats and President George W. Bush in 2007, which set exclusivity at five years.

“As members who support trade done right, we strongly believe that the [Trans-Pacific Partnership] must not inhibit access to lifesaving medicines,” the lawmakers wrote.

Rai said that a complicated mix of politics will decide the fate of the trade agreement. 

“It’s certainly a compromise, there’s no doubt about that,” Rai said. “In general, compromise in these areas seems to be better than one side entirely winning the game.”

Congress needs to pay attention how the deal will affect the pharmaceutical industry and smaller companies that are doing the ground level research.

The agreement raises questions about whether they would continue researching certain drugs without longer exclusivity protections.

The post Big Pharma Angered Over The Trans-Pacific Partnership Agreement appeared first on Citizens Report.

Alexis Benter

Harvard researchers published a new study which found that many drugs used to treat H.I.V. are being set at unfairly high prices. The study examined health care plans in 12 states and found that the drugs were being priced using a system of “adverse tiering,” which placed essential life-saving drugs in a special category.

This category forces anyone in need to pay more than 30 percent of the cost of the drug. Not only did it place corporate drugs in the tier, but also all generics. This leaves individuals with chronic conditions no other option but to pay the high price. The price of once affordable generic medications has increased by more than 1,000 percent since the introduction of these policies.

Financial Repercussions: The Hardest Hit

Discriminatory pricing can have a massive financial impact on anyone who requires the drugs. The study also noted that drugs used to treat mental illnesses, cancer and other debilitating diseases were placed in a similar category. Because these drugs are life-saving, those in need are left with no choice but to pay an extremely high price.

The Obama administration stated that it would begin to investigate these pricing practices. The administration noted that by insurance companies placing all drugs that treat certain conditions in the highest tier price range, they are discriminating against individuals with that condition.

The relationship between the Obama administration and Big Pharma paints a telling picture. “The drug companies form the most powerful lobby in Washington. They never lose,” said Senator Bernie Sanders in an interview with LA Times. The Center for Responsive Politics conducted an analysis that concluded Big Pharma spent a whopping $227 million on its lobbying strategy in 2014. Big Pharma seems to have considerable control over the pens of Washington lawmakers.

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An example of their relationship can be seen in the $80 million savings deal that occurred between Washington and Big Pharma during negotiations for the Affordable Care Act. The deal prevented the president from attempting to write in provisions that would allow the cheaper importation of these drugs from Europe and Canada. The money of Big Pharma seems to carry more weight than the coins of those in need of life-saving drugs.

Thankfully, the fight against these policies rages on. More than 300 advocacy groups signed a letter urging Sylvia Burwell, the Health and Human Services Secretary, to take action against discriminatory pricing.

Discriminatory drug pricing is an unfair practice that makes life difficult for those who already face the enormous burden of dealing with a chronic disease. As the Obama administration continues to look into these discriminatory practices, it is important to remain aware of the situation and not let an issue of this nature go unnoticed. Big Pharma may have lots of money in the pockets of Washington, but with increasing awareness and attention to the issue, positive changes can be made.

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A patent must be filed once a new drug is discovered. That patent will protect against competition for 20 years. The problem is a new drug cannot go to market until it has been clinically tested and FDA-approved. That means every year of testing is a year that pharmaceutical companies cannot profit off of their patent. This aspect of patent law influences pharmaceutical companies in deciding which medical ailments to dedicate their efforts on.

An Economist report explains how drug companies focus their R&D on seemingly incurable diseases that are likely to kill patients within a few years. That’s opposed to focusing on diseases that are more likely to be cured, but spend a longer time in clinical trials. The way pharmaceutical companies see it, it is not worth their while to save patients’ lives if the clinical trials take 18 years, because then they would only have 2 years left to sell their drug. Instead they focus on bettering the lives of patients that are sure to die over a short-time span. Because if they only have to test their drug for 3 years, then they’d still have 17 years left to sell it.

Pharmaceutical companies shouldn’t be blamed for this behavior. Drug research and development is very costly. The companies that produce ground-breaking prescription drugs deserve to profit off of them.

The Economist’s report shows how badly the patent system needs to be changed.

The post The Drug Patent System Is Killing Patients appeared first on Citizens Report.

That is the verdict of a recent case involving Roche, the manufacturer of Accutane. In 2011, a New Jersey jury awarded $2.1 million to Gillian Gaghan of California. Gaghan and nearly 8,000 other patients filed lawsuits against Roche, blaming their acne medication for inflammatory bowel disease (IBD), said Bloomberg.com. Roche disagreed with the verdict in Gaghan’s case. After deciding to fight back, Roche won. The $2.1 million settlement was reversed. It was this recent reversal case in which the judge decided that “a prescription drug manufacturer fulfills its duty to warn if it provides adequate warnings to the prescribing physician, and it has no duty to ensure that the warning reaches the patient.”

Adequate Warning

Responsibility falls on the prescribing doctor, as long as they’ve been adequately warned of a drug’s side effects. But what about when a pharmaceutical company does not provide proper information on a drug’s complications and potential injuries? In that case, the Big Pharma company would be held responsible, as they should. Sometimes pharmaceutical companies not only fail to properly warn doctors and patients (in marketing campaigns), but, more cynically, suppress side effect information in order to sell more drugs. In cases like that, Big Pharma deserves to pay the price for people’s pain and medical bills.

If you’ve been hurt by a prescription drug or medical advice, click here to view a list of ongoing lawsuits.

The post Who’s Responsbile For Prescription Drug Side Effects? appeared first on Citizens Report.

A drug’s birth takes place in the laboratory. When a pharmaceutical company finds promising data in a study, they submit an Investigational New Drug application to The Center for Drug Evaluation and Research, a part of the FDA. Should the application be approved, the pharmaceutical company is then able to start testing the drug on HUMAN subjects to determine effectiveness. These experiments are known as CLINICAL TRIALs. If the pharmaceutical company then finds that the clinical trials prove effectiveness, they then submit a New Drug Application to the FDA.

At this point, the FDA will consider the risks vs rewards (benefits) of the new drug. As it would be expected, if the FDA finds that the benefits outweigh the risks, the drug will gain approval. Yet it should be noted that due to the small size of these premarketing clinical trials, the FDA DOES NOT and CANNOT learn everything about the drug’s safety prior to granting it approval. It is thus for this reason, that the FDA continues to monitor the drug even after issuing its approval. This of course makes sense and is done for our safety.

Unfortunately there have been many drugs that gained approval where the risks prove to outweigh any benefits. How could this happen? Perhaps the clinical trials were not well conceived and new or unforeseen side effects occur. Or there could be unclear labeling or even sub-standard manufacturing. Or previously known side effects such as the possibility of a stroke prove to be much higher than previously believed. Worse yet is the case where a drug company actually hides potentially serious side effects.

While no one may be able to take away the pain and suffering that countless patients and their families experience, THERE IS LEGAL HELP, help that can assist with medical and other expenses –  all with the aim of improving one’s quality of life.

To see a list of on-going prescription side effect lawsuits, click here!

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