In this week’s news, Zolgensma data mulled by FDA, US demand for surprise plant inspections and more…

US FDA assessing manipulated Zolgensma data

US FDA says the SMA gene therapy Zolgensma should stay on the market despite manufacturing data Novartis says were “manipulated.”

Last week Novartis announced that some data submitted in the Zolgensma biologics license application (BLA) were inaccurate.

According to the Swiss firm, Avexis found out about alleged data manipulation during animal testing and notified the agency on June 28 after an internal investigation.

Zolgensma is the first and only therapy approved for spinal muscular atrophy (SMA). The issue – say the BMJ and STAT – is that the US FDA approved the product in May.

In its response the FDA said it has concerns about “a small portion of the product testing data that was contained in the marketing application” but that Zolgensma should stay on the market.

The agency made clear the manipulated data relate to the manufacturing process rather than Zolgensma’s safety or efficacy.

“We are carefully assessing the issue of the manipulation of the product testing data used in the production process and are conducting a thorough assessment of the information from a recently completed inspection.”

The FDA added that, “We are also aware that Avexis became aware of the issue of the data manipulation that created inaccuracies in their BLA before the FDA approved the product, yet did not inform the FDA until after the product was approved.

“The agency will use its full authorities to take action, if appropriate, which may include civil or criminal penalties.”

Call for surprise US FDA inspections of overseas plants

A US politician wants the US FDA to conduct surprise inspections of overseas drug manufacturing facilities.

Republican Senator Chuck Grassley made the call in a letter to Alex Azar Secretary Department of Health and Human Services and Norman Sharpless Acting Commissioner Food and Drug Administration last week.

Grassley cited moves to increase importation, writing “drug importation will help to reduce drug costs for American consumers and patients… However, I have also noted that my position is predicated on the FDA ensuring the safety and efficacy of those drugs.

He also pointed out the US’ reliance on active pharmaceutical ingredients and drugs made outside the country.

I strongly encourage the administration’s demonstration projects to include unannounced inspection in foreign manufacturing facilities to determine whether they meet the required active pharmaceutical ingredients and drug quality and safety standards to include sufficient record-keeping, testing and protections against counterfeiting,” Grassley said.

The letter comes days after the Pentagon flagged Chinese made APIs as a potential national security threat.

Also in the news

The cell therapy sector is in a cost of goods crisis according to an expert quizzed by Bioprocess Insider.

Candidates vying for the US presidency should be talking about potential drug shortages according to STAT.

Pharmabiz looked at Lupin’s efforts to ensure it complies with US manufacturing regulations.

The US GAO published a report on the US generic drug sector.

The major finding – according to the FDALawblog – is that products usually undergo multiple review cycles.

The FDA asked for feedback on opioid product packaging plan.

CDMO trends

Some developments of note in the CDMO space.

Cambrex Corporation has signed an agreement to be acquired by private equity fund Permira for $2.4 billion. The fund’s current holdings include Swiss medical equipment services firm, Althea and US CDMO, LSNE.

Thermo Fisher Scientific-owned Brammer Bio is seeking tax increment financing for a new manufacturing facility in Norton, Massachusetts. See more details at FiercePharma.

Eurofins has acquired US gene synthesis contractor Blue Heron Biotech. The deal is designed to bolster Eurofins Genomics production capabilities, particularly in the area of DNA oligonucleotides.