More drug companies are getting swept into the congressional onslaught against large price increases, with little attention paid to the reason for the hike.

Last week, Ariad Pharmaceuticals Inc., of Cambridge, Mass., found itself in the congressional dustbin with repeat price-hiker Valeant Pharmaceuticals International Inc. While Laval, Quebec-based Valeant has a reputation for buying older drugs and then jacking up their prices, Ariad is a startup, research-based company that has yet to turn a profit.

In response to a blistering letter from Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) about the escalating price of its leukemia drug, Iclusig (ponatinib), Ariad pointed out the realities facing a small research-focused biopharma. With Iclusig its only product on the market, Ariad generated $119 million in revenue last year while investing $171 million in R&D. The company also noted that since its founding, it has invested more than $1.3 billion in R&D and has accumulated losses of about $1.4 billion, which have yet to be recovered.

Before Iclusig was approved in the U.S. in December 2012 to treat certain patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia, the drug was seen as a potential blockbuster because of its 56 percent response rate. But a boxed warning chilled some of the enthusiasm ahead of the drug's launch at a list price of $115,000. (See BioWorld Today, Dec. 17, 2012.)

Within a year of the approval, the FDA asked Ariad to suspend sales of Iclusig and halt clinical trials due to safety issues. When the agency allowed sales and research to continue, it further limited the indication, added more warnings to the label, required Ariad to develop a risk evaluation and mitigation strategy, and told the company it had to conduct additional postmarket investigations.

Ignoring the cost of those measures and the reduced patient population for Iclusig, Cummings and Sanders decried the continuing price hikes for the drug, which now has a list price of $199,000 per year, as "outrageous sales tactics [indicating] that Ariad is more concerned with its profit than with its patients."

As it is, Ariad slashed 90 positions in the U.S. and Europe earlier this year so it could continue to invest in the clinical development of Iclusig and its second product, brigatinib, which was submitted to the FDA in August for accelerated approval for the treatment of metastatic ALK-positive non-small-cell lung cancer in patients who are resistant or intolerant to Pfizer Inc.'s Xalkori (crizotinib). (See BioWorld Today, April 12, 2016, and Aug. 31, 2016.)

News of the congressional inquiry into its pricing strategy sent Ariad's shares (NASDAQ:ARIA) downward more than 14 percent from the market close of $10.81 Wednesday, the day before Cummings and Sanders sent the letter. Ariad closed at $9.37 Monday, down $1.01.

The story is different for Valeant, which has been hauled before congressional committees to answer for what lawmakers have described as a buy-and-hike business model that has sent the price of several older drugs soaring. This time, Rep. Dan Kildee (D-Mich.) is calling on Congress to investigate the company's 2,900 percent increase in the price of calcium disodium versenate (CDV), a sterile, injectable formulation of calcium EDTA that's used to treat acute cases of lead poisoning and lead encephalopathy. (See BioWorld Today, Feb. 5, 2016.)

Although it was approved by the FDA in 1953, CDV has no therapeutic equivalents in the U.S. When Valeant bought the drug in 2013 as part of an acquisition of another company, a package of CDV vials was selling for $950. By the end of 2014, Valeant had raised the price to more than $26,900.

"Valeant's price gouging for this life-altering drug is corporate greed at its worse," Kildee said as he requested an investigation into the pricing of the drug.

Valeant was quick to point out that the list price doesn't reflect the actual cost hospitals pay for the product. It also noted the low demand for the drug, which it said is about 200 to 300 units per year. "Because CDV has a relatively limited shelf life and the minimum CDV purchase requirement for Valeant is roughly three to five times higher than recent annual sales volume, we have written down at our own expense approximately half of purchased quantities in the past few years," the company said, adding that sales of the drug represent less than 0.01 percent of its total revenue.

FDA SPOTLIGHTS AD ANIMATION

With animation becoming more common in prescription drug commercials, the FDA wants to know what effect those characters are having on how consumers respond to the commercial and the drug.

The concern is that the entertainment aspects of animation may distract from learning key information. "It is important to examine whether animation in drug ads inflates efficacy perceptions, minimizes risk or otherwise hinders comprehension of drug risks and benefits," the agency said in an information notice slated for publication in Tuesday's Federal Register.

The FDA is proposing a two-part study, using mock drugs for chronic dry eye and psoriasis, to determine whether nonhuman personification in animated drug ads influences comprehension, processing and the perception of risk and benefit information. The first experiment will examine two types of animation in addition to a control ad using live actors. It is designed to demonstrate whether animation itself influences consumer recall of risks and benefits, perceptions of risks and benefits, and attitudes and emotional responses to the ad, the brand, the product and the animated character.

In the second experiment – which will examine whether the object of the animation has an impact – the animated character will personify either the sufferer of the medical condition, the disease itself or the benefit from the drug. Comments on the information request are due by Nov. 24.

GDUFA COMMENT PERIOD EXTENDED

To comply with federal law, the FDA has extended the comment period for the proposed user fee agreement it reached with the generic drug industry to Nov. 16.

In September, the agency announced a public meeting on GDUFA II and set a comment deadline of Nov. 7. However, it didn't post the draft recommendations until Oct. 14. Federal law requires a 30-day comment period after the recommendations have been made public.