Regulatory Focus™ > News Articles > RegBits: 5 Things to Know About Healthcare Product Regulation Today (15 September 2014)

RegBits: 5 Things to Know About Healthcare Product Regulation Today (15 September 2014)

Posted 15 September 2014 | By Alexander Gaffney, RAC

RegBits: 5 Things to Know About Healthcare Product Regulation Today (15 September 2014)

Welcome to RegBits, a new way to get an at-a-glance look at important regulatory news stories. Today's top stories include the US Department of Justice going after Bayer, a shortage of breast implants in Venezuela, a historic drop in the number of generic drug submissions to FDA, new efforts to improve the safety and efficacy of ophthalmic drugs and strange happenings at FDA's docket office.

DOJ Goes After Bayer

Pharmaceutical and consumer products giant Bayer has found itself in the crosshairs of the US Department of Justice (DOJ) after allegedly violating a 2007 court order which prohibited the company from making "unsubstantiated claims" about the dietary supplement products it markets.

Under US law, companies are limited in the claims they can make about a healthcare product unless they have "substantial evidence" which has undergone review by the US Food and Drug Administration (FDA). In general, dietary supplements are limited to making health claims that show they support the general "structure" or "function" of the body.

"The court order prohibits Bayer from making any claim about the performance or efficacy of any dietary supplement, multivitamin or weight-control product unless, at the time Bayer makes the claim, the company possesses “competent and reliable scientific evidence” to support the claim," DOJ recalled. However, Bayer made numerous claims that its Philips' Colon Health product could "defend against" constipation, diarrhea, gas and bloating, DOJ charged. The Federal Trade Commission (FTC) had brought the matter to the DOJ's attention, it said.

In a statement, Bayer said its products' health claims were "fully substantiated and supported," and that it disagreed with DOJ's filing. Also in a statement, the Consumer Healthcare Products Association (CHPA) called the case indicative of a "growing federal drift away from the longstanding legal standards for substantiating dietary supplement claims," and called the government's "increasingly rigid application" of evidentiary requirements "alarming."

(DOJ) (CHPA)

Drug Shortages, Meet Device Shortages

Drug shortages may be a serious problem both here in the US and around the world, but they aren't the only healthcare products subject to shortages.

The Associated Press this weekend reported that economic policies in Venezuela are leading to a shortage of high-quality breast implants, which are highly sought-after in the country, which the AP says has one of the world's highest plastic surgery rates.

While US-approved devices were once readily available in the country, "restrictive currency controls" have made it difficult to import the goods, the AP explained. As a result, the country is turning to cheaper, potentially lower-quality Chinese and black market implants instead.

(AP)

Generic Drug Submissions at All-Time Low

Generic drug submissions reached an all-time low in August 2014, Bob Pollack, a former official in FDA's Office of Generic Drugs (OGD) reported this week. However, that submission number could soon rise dramatically, as firms appear to be holding off on submitting applications until 1 October 2014, when new performance requirements come into effect under the Generic Drug User Fee Act (GDUFA).

In September, as in August, OGD received just four original abbreviated new drug applications, Pollack wrote. In contrast, OGD received 635 ANDAs in the first 19 days of June 2014, Pollack said. That surge was due to an expiring stability standard, however.

(Lachman Consultants)

Eye Contract Awarded

FDA has issued a $200,000 contract to Simulations Plus, a software provider, to develop new models and simulations intended to improve models of how ophthalmic drugs are absorbed into the eye.

"The improvements to our ocular model to be developed under this agreement will aid the FDA in developing regulatory science and policies in the area of absorption of drugs applied to the eye, and it will aid the generic pharmaceutical industry in designing high quality products that meet public expectations for effectiveness," the company said in a statement.

The company will be working alongside FDA in the cooperative contract, it said.

Simulations Plus noted that the global market for ophthalmic drugs was $16 billion, and is expected to increase to more than $21 billion by 2018.

(Simulations Plus)

Correction, Correction, Correction…

Regular watchers of the US Food and Drug Administration's (FDA) Federal Register docket know that errors in FDA's documents are exceedingly rare. But this month has proven to be a strange exception, with FDA issuing no fewer than 12 "correction" notices since 14 August 2014 to remedy minor errors in the documents.

While most of the errors were minor—an incorrect submission date or a wrong docket number—we can't help but wonder what's led to this sudden surge in problems.

  1. Public Inspection: Guidance: Electronic Submission of Lot Distribution Reports; Correction
  2. Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction
  3. Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections
  4. Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction
  5. Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications; Correction
  6. Advisory Committee Renewals; Correction
  7. Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction
  8. Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections
  9. Biosimilar User Fee Rates for Fiscal Year 2015; Correction
  10. Outsourcing Facility Fee Rates for Fiscal Year 2015; Correction
  11. Medical Devices; Technical Amendment
  12. Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction

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Categories: Regulatory News

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