Senators ask FTC to investigate saline suppliers over shortages and pricing
October 27, 2015 | Antitrust, FTC, Pricing & Patient Access
By Ed Silverman

Four US Senators have asked the Federal Trade Commission to investigate whether suppliers of saline solution have illegally inflated prices in order to exploit chronic shortages of the product, which is a fixture in hospitals across the country.

Since shortages began two years ago, the companies reportedly increased their prices by 200 percent to 300 percent. In a letter to FTC chairwoman Edith Ramirez, the senators contend that costs have increased for hospitals by hundreds of thousands to millions of dollars a year. Read More


The eyes have it: FTC probes Valeant over contact lens
October 27, 2015 | Antitrust, Mergers and Acquisitions, Uncategorized
By Ed Silverman

The Federal Trade Commission is investigating whether Valeant Pharmaceuticals illegally cornered the market for a key component of rigid contact lenses, according to ProPublica. The drug maker disclosed recently that it received a letter from the FTC about an investigation into the purchase of a company that makes lenses, but did not provide further details.

The probe is the latest in a string of investigations into Valeant business practices. Presidential aspirant and Vermont Senator Bernie Sanders began investigating the company over its drug pricing. And federal prosecutors in New York and Massachusetts opened their own probe into patient assistance programs and information given to the US Centers for Medicare & Medicaid Services. Read More


Novartis to pay $390M to settle kickback case, but will execs pay a price?
October 27, 2015 | Bribes, Marketing, Uncategorized
By Ed Silverman

On the eve of a closely watched trial that was to have begun next week, Novartis has agreed to pay $390 million to settle charges of paying kickbacks to boost sales of various drugs. Prosecutors say the scheme caused federal healthcare programs to overpay for the company’s medicines. But will Novartis executives suffer any consequences?

Generally, the federal government resorts to large fines against companies, although, there are recent signs the government might be changing its approach toward recalcitrant executives. The US Department of Justice issued a memo instructing staff to pursue executives for wrongdoing. And the US Department of Health & Human Services formed a team to ban executives from doing business with federal healthcare programs. The Novartis deal isn't finalized, but some say the government should use this case to send a message. Read More


Pharmalot.. Pharmalittle.. Good Morning.. We’re catching up on Sanofi, Glaxo and…
October 27, 2015 | Cancer, Diabetes, FDA, Generics, Mergers and Acquisitions, Off-Label Promotion, Pricing & Patient Access, Quality Control, Uncategorized
By Ed Silverman

Good morning, everyone, and how are you today? We are just fine, thank you, and busy as ever. We are, in fact, on the road as we plan to huddle with the Stat folks about the upcoming launch of the Stat site, which is where we will be housed. This calls for a celebratory cup of stimulation and, as always, we invite you to join us. And now, we present your daily menu of tidbits. Hope your day goes well and, of course, keep in touch...

A new deadline of Nov. 16 was set for the FDA and Pacira Pharmaceuticals to try to resolve a closely watched legal battle over off-label marketing and free speech; A GlaxoSmithKline plant in China, which suffered an explosion last summer, had its Good Manufacturing Practice certificate revoked by the UK medicines regulator; and Sanofi's new ceo Olivier Brandicourt is expected to show how he will get the drug maker back on track, after being hit by lagging diabetes sales and boardroom rows, when he presents his five-year strategic plan on Nov. 6. Read More


Valeant has more explaining to do about its ties to pharmacies
October 26, 2015 | Marketing, Pricing & Patient Access
By Ed Silverman

In a fact-filled conference call this morning, executives at Valeant Pharmaceuticals tried to clarify the company’s convoluted ties to a mail-order pharmacy known as Philidor Rx Services. A bevy of murky details surrounding the relationship has called into question whether Valeant properly disclosed its business practices and fueled further skepticism about its growth prospects.

But whether the hour-long effort today had the intended affect is uncertain, at best. Valeant insisted its accounting practices are legal and reviewed arrangements between the companies. And to reassure Wall Street, Valeant formed an ad hoc board committee to review the relationship. But Valeant stock barely budged today, suggesting investors are unconvinced the drug maker has fully explained the extent to which Philidor is important to its operations. Read More


Amgen reviews privacy of patient assistance program for cholesterol drug
October 26, 2015 | Cholesterol, Patient Privacy, Pricing & Patient Access, Uncategorized
By Ed Silverman

In response to criticism, Amgen is reviewing privacy provisions in a patient assistance program for its pricey new cholesterol medicine which is called Repatha. Doctors and patient advocates recently complained it requires patients to surrender rights to their personal information, including personal health data. And the web site also states the information will be freely available, with few restrictions, to Amgen and unspecified third parties. Read More


Prescription drug price hikes are slowing this year… so far, anyway
October 26, 2015 | Alzheimer's, FDA, Generics, Pricing & Patient Access, Uncategorized
By Ed Silverman

The price tags for prescription drugs are a red-hot issue that is increasingly causing concern among consumers, physicians and insurers. Even some presidential aspirants are speaking out.

But how much are prices rising so far this year?

A new analysis finds that prices rose 9.1 percent through Sept. 30 for all types of medicines, which trails the 10.9 percent increase seen in 2014, according to Truveris, a health care technology firm that tracks drug pricing. Each month, the company regularly analyzes claims data involving more than 300 million payments to U.S. pharmacies for prescriptions and develops composite figures. Read More


Pharmalot.. Pharmalittle.. Good Morning.. We’re catching up on Valeant, Glaxo and…
October 26, 2015 | FDA, Mergers and Acquisitions, Pharmacy Benefit Managers, Pricing & Patient Access, Quality Control, Rare Diseases, Uncategorized
By Ed Silverman

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that all-too-familiar routine of meetings, deadlines and what-not has returned. To cope, as you may guess, we are brewing several cups of needed stimulation and invite you to join us. And why not? A prescription is not required, after all. Meanwhile, here are some items of interest. Have a smashing day and do stay in touch...

Valeant Pharmaceuticals maintains its accounting practices for the Philidor Rx Services pharmacy are appropriate, but created a board committee to review the relationship; The top executives of the largest Indian generic drug makers, including Dr Reddy's Laboratories, Sun Pharma and Lupin Pharmaceuticals, met informally in Mumbai to discuss ways of coping with FDA warnings and bans; and Read More


AbbVie, hepatitis C and patient deaths: What the wags say
October 23, 2015 | FDA, Hepatitis C, Patient Safety
By Ed Silverman

In a setback to AbbVie, the Food and Drug Administration yesterday warned of liver damage from its two hepatitis C treatments, setting off a chain reaction that is reverberating across the pharmaceutical industry. With as many as seven patient deaths and several liver transplants attributed to the drugs, AbbVie stock plummeted and Wall Street fortune tellers went to work betting on winners and losers.

The serious side effects are “likely to be fatal for (AbbVie) brand, at least in the US,” writes Sector & Sovereign Research analyst Richard Evans in an investor note. He pointed out Viekira Pak already generated more adverse events than either Gilead drug. And the only way AbbVie was able to retain market share was to entice payers to place its drug on formularies, the lists of preferred medicines. Read More


Pharmalot.. Pharmalittle.. As the weekend nears.. we’re catching up on Valeant and..
October 23, 2015 | Antibiotics, Cancer, FDA, Patents, Pricing & Patient Access, Research & Development, Uncategorized
By Ed Silverman

And so, another working week is about to draw to a close. Not a moment too soon, yes? This is, as you know, our treasured signal to daydream about weekend plans. To be honest, our agenda is rather modest. We hope to manicure the Pharmalot grounds, indulge our shortest of short people and catch up on some reading. And what about you? This is a lovely time of year to enjoy the great outdoors. You know, picking apples and that sort of thing. You could plan an end-of-year getaway. Or maybe reach out to someone special. Whatever you do, have a grand time, but be safe. See you soon...

Valeant Pharmaceuticals will hold an investor briefing on Monday to refute reports about its accounting that "contain numerous errors, unsupported speculation and incorrect interpretations of facts;" Speedier diagnostics that can distinguish between bacterial and viral infections are needed to combat unnecessary prescriptions for antibiotics, according to a report by the Review on Antimicrobial Resistance; and The latest biotechnology stock-market debut, Dimension Therapeutics, floundered yesterday, illustrating how the squeeze in new issues persists for one of the hottest segments of the initial public offering market. Read More