New book on quality issues in generic drugs sends FDA in damage control mode, 21 generic firms sued over price-fixing

New book on quality issues in generic drugs sends FDA in damage control mode; 21 generic firms sued over price-fixing

By PharmaCompass

2019-05-16

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This week, Phispers is loaded with news from the US.

First, a coalition of 44 states sued Teva and 20 other generic companies for price fixing.

Second, a new book titled ‘Bottle of Lies’, by investigative journalist Katherine Eban revealed how quality and efficacy of generic drugs in being compromised by companies in India and China, who produce these drugs for the US consumer.

The book release sent the FDA in damage control mode, with senior officials issuing statements supporting the agency’s generic drug framework.

As if this wasn’t enough, the Trump administration brought in a rule that drug companies need to put list price of their medicines in TV commercials.

AbbVie and Boehringer Ingelheim resolved their patent dispute in the US over Humira biosimilar.

An IQVIA report said the prescription opioid volume in the US market has dropped 43 percent since their 2011 peak.

And Takeda sold its dry-eye drug Xiidra to Novartis in a deal worth US$ 5.3 billion.

Teva, 20 other generic drugmakers sued by 44-state coalition in US over price-fixing

In the US, a coalition of 44 states sued Teva Pharmaceuticals USA Inc and 20 other companies for orchestrating a sweeping scheme to inflate drug prices, sometimes by more than 1,000 percent. This way, they stifled competition for generic drugs, the state prosecutors said.

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The 500-page lawsuit accuses the generic drug industry of a long history of discreet ‘price fixing’ agreements. At the height of the conspiracy (from July 2013 to January 2015), the price of one blood pressure medication increased by as much as 2,700 percent.

The complaint pertains to 116 common medications, including everyday antibiotics, antidepressants, contraceptives, drugs to treat conditions like diabetes, high cholesterol, high blood pressure, cancer, epilepsy etc.

Besides Teva, the lawsuit names Sandoz, Mylan, Pfizer, Actavis, Amneal, Apotex, Aurobindo, Breckenridge, Dr Reddy’s Laboratories, Glenmark, Greenstone, Lannett, Lupin, Par, Rising, Taro Israel, Taro USA, Upsher-Smith, Wockhardt USA and Zydus.

Attorney General Ferguson said: “This is one of the most damaging price-fixing conspiracies in history — we’re going to hold those responsible accountable.”

The lawsuit also names 15 individuals as defendants who it said carried out the schemes on a day-to-day basis. The lawsuit is parallel to an action brought in December 2016 by the attorneys general of 45 states and the District of Columbia. That case was later expanded to include more than a dozen drugmakers.

The generic industry has vehemently denied the allegations. Teva’s chief financial officer Mike McClellan said the company has done nothing wrong. He told a conference in Israel that the suit was an amended one and not new, while stressing it was civil and not criminal.

New book on quality issues in generic drugs sends FDA in damage control mode

Six years ago, journalist Katherine Eban had created a stir in the global pharmaceutical industry with her eye-opening, investigative report published in Fortune titled ‘Dirty Medicine’ on the blatant data falsification at Indian drug major Ranbaxy.

Eban is back with her exposes on the drug industry, this time in the form of a book titled ‘Bottle of Lies’. In a recent article published in the New York Times, Eban shared how famous FDA investigator Peter Baker uncovered data-integrity issues in India and China.

According to Eban, during his six years of doing foreign inspections (from 2012 to 2018), Baker uncovered “dangerous compromises behind the production of generic drugs”. Both in India and then in China, Baker uncovered fraud or deceptive practices in almost four-fifths of the drug plants he inspected. Some of the plants used hidden laboratories, secretly repeated tests and altered results to produce fake data that fundamentally misrepresented drug quality, and then submitted that data to regulators.

“In some instances, deceptions and other practices have contributed to generic drugs with toxic impurities, unapproved ingredients and dangerous particulates reaching American patients,” Eban said.

Eban interviewed over 240 people, including numerous whistle-blowers, for her book. “Some companies have encouraged data fraud as the most profitable path to securing approvals from regulators, and have used deceit to hold the FDA’s investigators at bay,” Eban said.

“In the United States, FDA investigators typically show up unannounced to inspect plants. But overseas, the FDA has opted to announce the vast majority of its foreign inspections in advance. Overseas plants even ‘invite’ the FDA to inspect; the investigators then become the company’s guests and agree on an inspection date in advance. Plant officials have served as hosts and helped to arrange local travel,” she said.

In the wake of Eban’s book launch, other news reports on the safety and efficacy of generic drugs got published. A CBS News report said that though the FDA says a generic medicine is the same as a brand name medicine in dosage, safety…and quality, “experts at the Cleveland Clinic have determined some generics aren't a close-enough match for their comfort. Even a small variance in the drug may pose serious risks for some patients”.

Following these reports, the FDA went into damage control mode. In a tweet, former FDA commissioner Scott Gottlieb said: “I take generic drugs and have extreme confidence in them. I prescribed them to help my patients achieve value in their healthcare. Some bad problems arose years ago. We learned from them; and responded. Today's generic drug framework is vigilant and upholds FDA’s gold standard.”

Similarly, Janet Woodcock, director of the Centre for Drug Evaluation and Research (CDER), said in a statement: “Generic drugs are held to a rigorous approval standard and are as safe and effective as brand name drugs. Importantly, generic drugs manufactured outside the US must meet the same approval standards as those made domestically; and if they do not meet the FDA’s standards, the FDA can deny them entry into the US”.

In an interview published on the FDA website, Michael Kopcha, director of CDER’s Office of Pharmaceutical Quality said: “The quality of our drug supply is better than ever before. There is no difference in the quality of drugs based only on where they are made. We use the same tools to assure quality whether a drug is manufactured in the United States or abroad.”

Prescription opioid volume in US dropped 43 percent since 2011 peak, says IQVIA report

The war against opioids in the US is beginning to show positive results. The latest report from the IQVIA Institute for Human Data Science has found that the prescription opioid dosage volume — as defined by morphine milligram equivalents, or MMEs — declined 17 percent in 2018. This is the single-largest annual drop ever recorded within the US market.

The study titled ‘Medicine Use and Spending in the US: A Review of 2018 and Outlook to 2023’ shows prescription opioid volume had increased annually since 1992, reaching its highest level in 2011.

“Prescription opioid volume has declined 43 percent since the peak in 2011, with high-dose prescriptions of 90 MMEs per day or greater declining by 61 percent, while prescriptions for fewer than 20 MMEs have largely remained stable,” the report said.

Thanks to a series of regulatory and legislative restrictions, coupled with tighter clinical prescribing guidelines and greater reimbursement controls, opioid dosage volumes on an average decreased by 4 percent-per-year from 2012 through 2016, followed by a 12 percent drop in 2017 and the historic 17 percent decline last year.

According to the IQVIA report, net total spending on medicines in the US is expected to reach US$ 405–435 billion in 2023, up from US$ 344 billion in 2018. This includes spending across all channels and product types.

Americans filled 5.8 billion 30-day equivalent prescriptions in 2018, up 2.7 percent over the previous year at a rate of 17.6 prescriptions per person. More than two-thirds of prescriptions are for chronic conditions, which are increasingly filled with 90-day prescriptions thought to result in better adherence to prescribed regimens

AbbVie, Boehringer resolve US patent dispute over Humira biosimilar

AbbVie Inc and Boehringer Ingelheim GmbH have resolved their US patent dispute over a biosimilar to AbbVie’s Humira (adalimumab), the world’s largest-selling drug.

AbbVie said it would grant Boehringer Ingelheim (BI) a non-exclusive license to its Humira-related intellectual property in the US, permitting it to begin selling its Humira biosimilar — Cyltezo — in the US from July 2023.

“Boehringer will pay royalties to AbbVie for licensing its Humira patents and acknowledges the validity and enforceability of the licensed patents. AbbVie will make no payments of any form to BI,” an AbbVie statement said.

“We are pleased by this favorable decision from the PTO (Patent and Trademark Office), as it represents an important step towards our goal of providing an adalimumab biosimilar to the many patients who rely on this medication,” Boehringer said in a statement.

Biosimilars are near-copies of biologic drugs that are made from living cells and are analogous to generic copies of traditional pill-form medicines.

Humira, a drug used to treat diseases like rheumatoid arthritis and gut disorders, had nearly US$ 20 billion in global sales in 2018, accounting for about 61 percent of AbbVie’s total revenue. But AbbVie saw a 5.6 percent decline in Humira revenue in the first quarter this year, as competition from biosimilars led to a nearly 28 percent drop in sales overseas.

Sales of Humira biosimilars began in Europe late last year after a key AbbVie European patent expired. In the US, a group of US patents built up by AbbVie has prevented its launch.

Takeda sells dry-eye drug to Novartis in US$ 5.3 billion deal

Swiss drug major Novartis is buying dry-eye drug — Xiidra — from Japanese drug major Takeda Pharmaceutical for up to US$ 5.3 billion. The deal involves an upfront payment of US$ 3.4 billion, and milestone payments of up to US$ 1.9 billion.

Takeda is selling the drug to reduce the debt incurred for its US$ 62 billion acquisition of Irish drugmaker Shire Plc. It aims to dispose of US$ 10 billion worth of assets to cut debt. It is also selling TachoSil, a surgical patch for bleeding control, to Johnson & Johnson’s Ethicon for US$ 400 million.

For Novartis, the acquisition of Xiidra will beef up its eye-care portfolio. Expected to close after July, the transaction also includes 400 Takeda employees. According to analysts from Bank Vontobel in Zurich, these employees will give Novartis a marketing team to sell not only Xiidra but another prospective eye drug entrant — RTH258 — that’s awaiting regulatory approval.

“Despite generic competition...we think that Xiidra is sufficiently differentiated,” Vontobel analyst Stefan Schneider said. “The market (is) big enough for it to reach blockbuster status, justifying the price.”

With sales of US$ 400 million, Xiidra competes with Allergan’s older dry-eye drug Restasis. Xiidra has bagged regulatory approval in markets such as US, Canada and Australia.

Drug companies in US mandated to put list price in TV commercials

In the US, the Trump administration last week brought in a regulation that requires drugmakers to put the list price of their drugs in television advertisements. The regulation applies to all drugs covered by Medicare or Medicaid, if it costs at least US$ 35 for a month’s supply or the usual course of treatment. The administration published this rule in the Federal Register on May 10, and it is set to become effective on July 9.

It appears that self-policing didn’t bring the required results though some drug companies, like Johnson & Johnson’s and Eli Lilly, had released TV ads with the list prices of their drugs.

With this ruling, consumers will be able to “make informed decisions and demand value from pharmaceutical companies,” Centers for Medicare and Medicaid Services Administrator Seema Verma said in a statement.

According to the Department of Health and Human Services (HHS), the 10 most commonly advertised drugs in the US have list prices ranging from US$ 488 to US$ 16,938, though many patients with insurance do not pay the full amount.

“Patients have a right to know, and if you’re ashamed of your drug prices, change your drug prices,” HHS Secretary Alex Azar said.

Drug companies are largely opposed to the regulation. The Pharmaceutical Research and Manufacturers of America (PhRMA), a drug trade group, has already voiced opposition to the measure.

“We are concerned that the Administration’s rule requiring list prices in direct-to-consumer (DTC) television advertising could be confusing for patients and may discourage them from seeking needed medical care,” a representative of PhRMA said.

While no company has sued the Trump administration, the Association of National Advertisers (ANA) is “seriously considering trying to find a way to block” what it thinks is an “unconstitutional proposal by the HHS,” said Dan Jaffe, head of ANA's government relations office.

The American Medical Association, which has called for a ban on DTC ads in the past, said the rule is “a step in the right direction.”

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